Acetaminophen/Phenylephrine hydrochloride/Chlorpheniramine maleate/Dextromethor…

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold, flu, or hay fever. The specific symptoms it addresses include:

• Minor aches and pains

• Headache

• Sore throat

• Cough due to minor throat and bronchial irritation

• Nasal congestion

• Runny nose

• Sneezing

• Stuffy nose

• Sinus congestion and pressure

• Itchy, watery eyes due to hay fever

• Itching of the nose or throat

Additionally, this drug is indicated to temporarily reduce fever.

Limitations of Use

• The drug is not indicated for the treatment of chronic cough due to smoking, asthma, or emphysema.

• It is not intended for use in children under a certain age unless specified by a healthcare provider.

Special Considerations

• No teratogenic or nonteratogenic effects have been mentioned in the available data.

Dosage and Administration

Adults and children 12 years and older are advised to take 2 capsules, tablets, or caplets every 4 hours, while symptoms persist. The maximum dosage should not exceed 10 to 12 units in a 24-hour period, depending on the specific product, or as directed by a healthcare professional. It is important to swallow the tablets or caplets whole and not to crush, chew, or dissolve them.

For children aged 6 to under 12 years, the recommended dosage is typically 1 tablet every 4 hours, not to exceed 5 doses in 24 hours, or as directed by a doctor. For children aged 4 to under 6 years, dosing should only be done if directed by a healthcare professional. Children under 4 years of age should not use these products unless specifically directed by a doctor.

For liquid formulations, such as suspensions, it is essential to shake well before use and measure the dose using the provided dosing cup. The dosing should be repeated every 4 hours while symptoms persist, with a maximum of 5 doses in a 24-hour period for children. The dosing for children aged 6 to 11 years is typically 10 mL, while children aged 4 to 5 years should not use the product unless directed by a doctor.

All products should be taken orally with water, and it is crucial to adhere to the recommended dosages to avoid potential overdose, which may lead to serious health risks.

Contraindications

Do not use with any other drug containing acetaminophen (prescription or nonprescription). If unsure whether a drug contains acetaminophen, consult a doctor or pharmacist.

Do not use if currently taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If uncertain whether a prescription drug contains an MAOI, consult a doctor or pharmacist before use.

Do not use if allergic to acetaminophen or any of the inactive ingredients in the product.

Do not use in children under 12 years of age unless directed by a doctor.

Do not use in children under 4 years of age.

Do not use to make a child sleepy.

Do not use for persistent or chronic cough, such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor.

Do not use if taking sedatives or tranquilizers without first consulting a doctor.

Do not exceed the recommended dosage.

Avoid alcoholic beverages while taking this product.

Do not drive or operate machinery if drowsiness occurs.

Warnings and Precautions

Liver Warning This product contains acetaminophen. Severe liver damage may occur if:

• An adult takes more than 4,000 mg of acetaminophen in 24 hours.

• A child takes more than 5 doses (10 mL) in 24 hours, which is the maximum daily amount.

• Taken with other drugs containing acetaminophen.

• An adult has 3 or more alcoholic drinks every day while using this product.

Allergy Alert Acetaminophen may cause severe skin reactions. Symptoms may include:

• Skin reddening

• Blisters

• Rash

• Hives

• Facial swelling

• Asthma (wheezing)

• Shock If a skin or general allergic reaction occurs, stop use and seek medical help right away.

Sore Throat Warning If sore throat is severe, persists for more than 2 days, and is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

General Precautions

• Do not use with any other drug containing acetaminophen (prescription or nonprescription). If unsure, ask a doctor or pharmacist.

• Do not use if currently taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping the MAOI drug.

• Do not use if allergic to any of the ingredients in this product.

• Ask a doctor before use if you have:

  • Liver disease

  • Heart disease

  • High blood pressure

  • Thyroid disease

  • Diabetes

  • Glaucoma

  • A breathing problem such as emphysema or chronic bronchitis

  • Difficulty in urination due to enlargement of the prostate gland

  • Persistent or chronic cough such as occurs with smoking, asthma, or emphysema

  • Cough that occurs with excessive phlegm (mucus)

Get Emergency Medical Help In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Stop Taking and Call Your Doctor Stop use and ask a doctor if:

• Nervousness, dizziness, or sleeplessness occurs

• Pain, nasal congestion, or cough gets worse or lasts more than 7 days

• Fever gets worse or lasts more than 3 days

• Redness or swelling is present

• New symptoms occur

• Cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition.

Side Effects

Severe liver damage may occur if the maximum daily dosage of acetaminophen is exceeded, which varies by product. For adults, this limit is typically 4,000 mg in 24 hours, while for children, it is often 5 doses (10 mL for liquid formulations) in the same timeframe. Concurrent use with other acetaminophen-containing products or consumption of 3 or more alcoholic drinks daily while using these products significantly increases the risk of liver damage.

Serious Adverse Reactions

• Liver Damage: Symptoms may include jaundice, dark urine, or abdominal pain. Immediate medical attention is required in case of overdose.

• Severe Skin Reactions: Acetaminophen may cause severe skin reactions, including:

  • Skin reddening

  • Blisters

  • Rash

  • Hives

  • Facial swelling

  • Asthma (wheezing)

  • ShockIf any of these symptoms occur, discontinue use and seek medical help immediately.

Common Adverse Reactions

• Drowsiness: Marked drowsiness may occur, particularly when combined with alcohol, sedatives, or tranquilizers. Users should exercise caution when driving or operating machinery.

• Excitability: This effect is especially noted in children.

• Nervousness, Dizziness, or Sleeplessness: These symptoms may occur and warrant discontinuation of use and consultation with a healthcare provider.

Warnings and Precautions

• Sore Throat Warning: If a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

• Consult a Doctor If:

  • Pain, cough, or nasal congestion worsens or lasts more than 7 days.

  • Fever worsens or lasts more than 3 days.

  • Redness or swelling is present.

  • New symptoms occur.

  • Cough returns or occurs with a rash or headache that lasts.

Additional Considerations

• Users should avoid using these products if they have a history of liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or chronic respiratory issues such as emphysema or chronic bronchitis.

• It is advised to consult a healthcare provider before use if taking blood thinners like warfarin or if using sedatives or tranquilizers.

In case of overdose, immediate medical help should be sought or contact a Poison Control Center right away, as prompt medical attention is critical for both adults and children, even if no symptoms are present.

Drug Interactions

Acetaminophen, a common ingredient in several products, may significantly increase the risk of liver damage when taken concurrently with other medications containing acetaminophen or when consumed with three or more alcoholic drinks daily. Additionally, acetaminophen can enhance the effects of warfarin, leading to an increased risk of bleeding; therefore, it is crucial to monitor INR levels closely when these substances are used together.

Chlorpheniramine, another frequently included component, is known to cause marked drowsiness. The sedative effects of chlorpheniramine may be amplified when taken with alcohol, sedatives, or tranquilizers, increasing the risk of sedation. Caution is advised when combining these substances.

Dextromethorphan, found in some cold and cough formulations, may interact with monoamine oxidase inhibitors (MAOIs), which are used to treat certain psychiatric conditions. The use of dextromethorphan is contraindicated in patients taking MAOIs or within two weeks of discontinuing them due to the potential for serious side effects.

Warfarin users should consult a healthcare professional before using products containing acetaminophen or chlorpheniramine, as these may affect INR levels and increase the risk of bleeding.

In summary, careful consideration and monitoring are essential when using these medications, particularly in patients on anticoagulants or those consuming alcohol.

Pediatric Use

Pediatric patients under 12 years of age should not use several products, including Tabcin, Alka-Seltzer Plus Maximum Strength Cold and Cough Liquid Gels, Alka-Seltzer Plus Maximum Strength Cold and Cough Power Max Gels, and various formulations of Alka-Seltzer Plus Severe Cold and Flu. For these products, the recommended use is restricted to adults and children aged 12 years and older, with a typical dosage of 2 capsules or tablets every 4 hours, not exceeding 10 capsules or 8 tablets in 24 hours, unless directed by a healthcare provider.

For children aged 6 to under 12 years, Coltalin-Dm and Giltuss Multisymptom Cold and Flu can be administered. The dosing for Coltalin-Dm is 1 tablet every 4 hours, not to exceed 5 tablets in 24 hours. Giltuss Multisymptom Cold and Flu should be given at a dose of 5 mL every 4-6 hours, also not exceeding 5 doses in 24 hours.

Children under 6 years of age should not use Coltalin-Dm or Giltuss Multisymptom Cold and Flu unless directed by a doctor. For the Children's Plus Multi Symptom Cold, the product is indicated for children aged 6-11 years, with specific dosing based on weight. Children weighing 48-95 lb should receive 10 mL, while those weighing 36-47 lb should not use the product unless directed by a doctor. Children under 36 lb and those under 4 years of age should not use this product.

Caution is advised as some products may cause excitability, particularly in children. Additionally, severe liver damage may occur if the maximum recommended doses are exceeded, especially with products containing acetaminophen. In cases of overdose, prompt medical attention is critical for both adults and children, even if no symptoms are present.

Geriatric Use

Elderly patients may not have specific dosage adjustments or safety concerns outlined for the products reviewed. However, general precautions are advised. It is recommended that elderly patients consult a healthcare provider before use if they have underlying conditions such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or difficulty in urination due to prostate enlargement.

Marked drowsiness is a common warning associated with these products, which may be exacerbated by the use of alcohol, sedatives, or tranquilizers. Therefore, caution is advised when driving or operating machinery. Given the potential for increased sensitivity to side effects in geriatric patients, careful monitoring and consultation with a healthcare professional are recommended prior to use.

Pregnancy

Pregnant patients should consult a healthcare professional before using any of the following medications, as safety during pregnancy has not been established for these products. The use of these medications may pose risks to fetal outcomes, and healthcare providers can offer guidance based on individual circumstances.

All listed products, including various formulations such as capsules, tablets, and liquids, carry the recommendation to seek professional advice if the patient is pregnant or breastfeeding. This precaution is essential to ensure the safety of both the mother and the developing fetus.

No specific risk categories or study results are provided in the available data; therefore, healthcare professionals are advised to evaluate the potential benefits and risks of these medications on a case-by-case basis.

Lactation

Lactating mothers are advised to consult a healthcare professional before using any of the products listed, as there are no specific warnings or recommendations regarding lactation provided in the available data.

While the excretion of these medications in breast milk is not detailed, the general guidance across multiple labels indicates a cautious approach during breastfeeding. This is particularly important for products such as Tabcin, Alka-Seltzer Plus Maximum Strength Cold and Cough Liquid Gels, Coltalin-Dm, Sanaflu Xtra, and others, which all recommend consulting a healthcare professional if the mother is pregnant or breastfeeding.

No specific effects on breastfed infants have been documented in the provided information, but the absence of warnings does not imply safety. Therefore, healthcare providers should evaluate the potential risks and benefits of these medications for lactating mothers and their infants.

Renal Impairment

Patients with renal impairment may require special considerations when using certain medications. While many products do not provide specific information regarding dosage adjustments or monitoring for patients with reduced kidney function, there are notable exceptions.

For instance, Alka-Seltzer Plus Severe Cold and Flu Powerfast Fizz advises patients to consult a doctor before use if they have kidney problems or renal impairment. It also indicates that special monitoring may be necessary and that dosage adjustments could be required for those with reduced renal function. Additionally, renal function tests should be considered for patients with a history of kidney disease.

In general, for medications lacking specific guidance on renal impairment, healthcare providers should exercise caution and consider individual patient circumstances, particularly in cases of significant renal dysfunction. It is advisable for patients to discuss their renal health with their healthcare provider before starting any new medication, especially if they have a history of kidney issues or experience difficulty in urination.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using products containing acetaminophen due to the risk of severe liver damage. It is advised that individuals with liver disease consult a healthcare professional before using these medications.

The maximum daily doses for various formulations containing acetaminophen are as follows:

• Capsules and Tablets: The maximum daily amount typically ranges from 10 to 12 tablets or capsules, with a total acetaminophen limit of 3,250 mg to 4,000 mg in 24 hours. Specific products may have different maximums, so it is essential to refer to individual product labeling.

• Suspensions for Children: The maximum daily dose is generally limited to 5 doses (10 mL) in 24 hours.

Patients should be aware that taking acetaminophen with other medications containing acetaminophen or consuming three or more alcoholic drinks daily while using these products significantly increases the risk of liver damage.

In cases of overdose, immediate medical attention is critical, even if no symptoms are present. Monitoring liver function may be necessary for patients with existing liver conditions, and any signs of liver distress should prompt cessation of the medication and consultation with a healthcare provider.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222). Prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially observed.

Symptoms of overdose may include severe liver damage, particularly with products containing acetaminophen. For adults, taking more than 4,000 mg of acetaminophen within a 24-hour period can lead to severe liver damage. Specific products indicate that adults should not exceed 12 tablets in 24 hours, while children should not take more than 5 doses in the same timeframe. Additionally, combining these products with other medications containing acetaminophen or consuming three or more alcoholic drinks daily while using these products significantly increases the risk of liver damage.

It is essential to monitor for any signs of overdose and to act swiftly by contacting healthcare professionals for guidance.

Nonclinical Toxicology

Teratogenic Effects

No information regarding teratogenic effects is provided across the reviewed labels. However, it is advised that individuals who are pregnant or breastfeeding consult a health professional before use of certain products.

Non-Teratogenic Effects

Some products indicate potential non-teratogenic effects, such as excitability, particularly in children, and marked drowsiness, which may be exacerbated by the consumption of alcohol, sedatives, or tranquilizers. Additionally, an allergy alert is noted for acetaminophen, which may cause severe skin or allergic reactions, including symptoms such as skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), and shock.

Nonclinical Toxicology

No specific information is provided in the inserts regarding nonclinical toxicology for the reviewed products.

Animal Pharmacology and Toxicology

The reviewed labels do not contain specific details regarding animal pharmacology and toxicology.

Storage and Handling

Products are supplied in various forms including capsules, liquid-filled capsules, tablets, effervescent tablets, and suspensions.

All products should be stored at room temperature, with specific temperature ranges generally between 15°-30°C (59°F-86°F) or 20°-25°C (68°F-77°F). It is essential to avoid excessive heat, particularly temperatures above 40°C (104°F) for some formulations.

Certain products require additional handling precautions:

• Containers should be kept tightly closed and protected from light.

• Products should be stored in a dry place, away from direct sunlight.

• Tamper-evident seals should be checked; do not use if seals are broken or missing.

• For suspensions, it is recommended to shake well before use and to keep dosing cups with the product.

Expiration dates and lot numbers can typically be found on the packaging, and it is advised to retain cartons for complete product information and warnings.