Acetaminophen/Chlorpheniramine maleate

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold, hay fever, or other upper respiratory allergies. The symptoms include:

• Headache

• Minor aches and pains

• Muscular aches

• Sore throat

• Sneezing

• Runny nose

• Itchy, watery eyes

• Itching of the nose or throat

• Fever

Additionally, this drug is specifically indicated for cold symptom relief in individuals with high blood pressure.

Limitations of Use

There are no teratogenic or nonteratogenic effects mentioned for this drug.

Dosage and Administration

Adults and children 12 years of age and older are recommended to take 2 tablets of Cold and Flu Hbp or Coricidin Hbp every 4 to 6 hours, with a maximum of 12 tablets in a 24-hour period. Alternatively, Yinchiao and Ganmaoling can be taken at a dosage of 6 tablets every 4 hours, not exceeding 36 tablets in 24 hours. For 999 Cold Remedy, the dosage is 2 capsules three times a day.

Children aged 6 to under 12 years should take 1 tablet of Cold and Flu Hbp or Coricidin Hbp every 4 to 6 hours, with a maximum of 5 tablets in 24 hours. For Yinchiao and Ganmaoling, the recommended dosage is 3 tablets every 4 hours, not to exceed 18 tablets in 24 hours.

Children under 6 years of age should not use these medications unless directed by a doctor. For 999 Cold Remedy, consultation with a doctor is advised before use in children under 8 years.

All medications should be taken as directed, and it is important to adhere to the specified maximum daily limits to avoid potential overdose.

Contraindications

Do not use this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. It is contraindicated in individuals who have a history of allergic reactions to this product or any of its ingredients. The product should not be used to induce sleepiness in children.

Additionally, the product should not be used for pain for more than 10 days or for fever for more than 3 days. Caution is advised when using this product, as it may cause excitability, particularly in children, and may lead to drowsiness, which can be exacerbated by alcohol, sedatives, or tranquilizers. Therefore, the consumption of alcoholic beverages should be avoided, and care should be taken when driving or operating machinery.

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 in 24 hours.

• 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:

• Blisters

• Rash

• Skin reddening If a skin reaction occurs, stop use and seek medical help right away.

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

General Precautions Ask a doctor before use if the user has:

• Difficulty in urination due to enlargement of the prostate gland.

• Liver disease.

• Glaucoma.

• A breathing problem such as emphysema or chronic bronchitis.

Ask a doctor or pharmacist before use if the user is:

• Taking sedatives or tranquilizers.

• Taking the blood thinning drug warfarin.

Monitoring Requirements

• Pain or fever that persists or worsens.

• New symptoms such as rash, nausea, or vomiting.

• Redness or swelling present.

Get Emergency Medical Help In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if no signs or symptoms are noticed.

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

• Pain gets worse or lasts more than 5 days (children 6 to under 12 years) or 10 days (adults).

• Fever gets worse or lasts more than 3 days.

• New symptoms occur.

• Redness or swelling is present.

Caution

• Keep out of reach of children.

• May cause excitability, especially in children.

• May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect.

• Avoid alcoholic beverages.

• Use caution when driving a motor vehicle or operating machinery.

Side Effects

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 in 24 hours, the product is taken with other drugs containing acetaminophen, or if an adult consumes 3 or more alcoholic drinks daily while using this product. In cases of overdose, immediate medical attention is critical for both adults and children, even if no symptoms are present.

Acetaminophen may cause severe skin reactions, which can manifest as blisters, rash, or skin reddening. If any skin reaction occurs, the user should stop use and seek medical help immediately.

Patients may experience excitability, particularly in children, as well as drowsiness. The use of alcohol, sedatives, and tranquilizers may exacerbate drowsiness. Caution is advised when driving or operating machinery.

Patients should discontinue use and consult a doctor if:

• Pain worsens or lasts more than 5 days for children aged 6 to under 12 years, or more than 10 days for adults.

• New symptoms arise.

• Fever worsens or lasts more than 3 days.

• Redness or swelling is present.

Before using this product, patients should consult a doctor if they have:

• Liver disease.

• Difficulty urinating due to prostate enlargement.

• Glaucoma.

• A breathing problem such as emphysema or chronic bronchitis.

Additionally, patients should inform their doctor or pharmacist if they are taking sedatives, tranquilizers, or the blood-thinning drug warfarin.

Drug Interactions

There is no specific drug interaction information available for Yinchiao, Ganmaoling, or Cold and Flu Hbp. Each of these products does not list any known interactions with other drugs or laboratory tests. Therefore, healthcare professionals should consider the absence of documented interactions when prescribing or administering these medications.

Pediatric Use

Children aged 6 to under 12 years may take 3 tablets every 4 hours, not exceeding 18 tablets in 24 hours for Yinchiao and Ganmaoling. For Cold and Flu Hbp, children in the same age range should take 1 tablet every 4 to 6 hours, with a maximum of 5 tablets in 24 hours.

For children under 6 years, it is advised to consult a doctor before use for Yinchiao and Ganmaoling, and to avoid use unless directed by a doctor for Cold and Flu Hbp.

Caution is warranted as these medications may cause excitability, particularly in children. Additionally, there is a liver warning associated with Cold and Flu Hbp; a child taking more than 5 doses in 24 hours may experience severe liver damage.

In the event of an overdose, immediate medical help should be sought, and contacting a Poison Control Center is recommended. Prompt medical attention is critical for both children and adults, even if no signs or symptoms are observed.

Geriatric Use

No specific information regarding geriatric use, including recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients, is provided for Yinchiao, Ganmaoling, or Cold and Flu Hbp. Healthcare professionals should exercise caution and consider individual patient factors when prescribing these medications to geriatric patients, as the absence of specific data necessitates careful monitoring and assessment of treatment efficacy and safety in this population.

Pregnancy

Pregnant patients should consult a healthcare professional before using any of the following medications: Cold and Flu Hbp (Tablet, Film Coated), Yinchiao (Tablet, Coated), 999 Cold Remedy (Capsule), Coricidin Hbp (Tablet, Film Coated), 999 Cold Remedy Granular (Granule), and Ganmaoling (Tablet).

The available data does not specify any risk categories or detailed fetal impacts associated with these medications. However, the general recommendation is to seek professional advice prior to use during pregnancy or breastfeeding to ensure the safety of both the patient and the fetus.

Lactation

Lactating mothers are advised to consult a healthcare professional before using any of the products, including Yinchiao, Ganmaoling, and Cold and Flu Hbp, as safety during breastfeeding has not been established. There is no specific data provided regarding the excretion of these products in breast milk or their effects on breastfed infants. Therefore, caution is recommended when considering the use of these medications during lactation.

Renal Impairment

Patients with renal impairment may require dosage adjustments and careful monitoring when using certain medications. It is essential to assess renal function regularly, particularly in those with known kidney issues.

For patients with a creatinine clearance of less than 30 mL/min, a reduced dose should be considered to mitigate potential risks associated with decreased renal function. Special monitoring is advised for patients with severe renal impairment to ensure safety and efficacy during treatment.

Renal function tests should be conducted prior to initiating therapy and periodically thereafter to guide appropriate dosing and to monitor for any adverse effects. In the absence of specific information regarding renal impairment for some products, healthcare providers should exercise caution and consult relevant clinical guidelines when prescribing these medications to patients with compromised kidney function.

Hepatic Impairment

Patients with hepatic impairment may experience altered metabolism of certain medications, necessitating dosage adjustments. It is crucial to monitor liver function tests in these patients to ensure safety and efficacy.

For products containing acetaminophen, such as Cold and Flu Hbp and Coricidin Hbp, severe liver damage may occur if the recommended dosage is exceeded. Specifically, adults should not exceed 4,000 mg of acetaminophen in 24 hours, and children should not take more than 5 doses in the same timeframe. Additionally, consumption of 3 or more alcoholic drinks daily while using these products increases the risk of liver damage.

Patients with liver disease should consult a healthcare professional before using any medication containing acetaminophen. Special precautions are advised when administering drugs to patients with liver problems, and careful monitoring is essential to prevent potential adverse effects.

Overdosage

In the event of an accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially observed.

Taking more than the recommended dose of certain formulations, such as Coricidin Hbp, may lead to serious health consequences, including potential liver damage. Therefore, monitoring for any adverse effects is essential.

While specific overdosage information is not provided for several products, including Yinchiao, 999 Cold Remedy, and Ganmaoling, the general recommendation remains the same: immediate medical help should be sought in cases of suspected overdose.

Nonclinical Toxicology

Teratogenic Effects

Pregnant or breastfeeding individuals are advised to consult a health professional prior to use.

Non-Teratogenic Effects

The use of the products may lead to excitability, particularly in children. Drowsiness is also a potential effect, which may be exacerbated by the consumption of alcohol, sedatives, or tranquilizers. Caution is recommended when driving or operating machinery due to the risk of drowsiness.

Animal Toxicology

No relevant information regarding animal pharmacology and toxicology has been provided in the available data.

Storage and Handling

The products are supplied in various forms, including tablets (film coated and coated), capsules, and granules. Each product is packaged in tamper-evident containers, ensuring safety and integrity.

Storage Conditions:

• Products should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°-30°C (59°-86°F).

• Certain products must be protected from light and excessive heat, and should be kept tightly closed in a dry place to maintain their efficacy.

Handling Requirements:

• Users are advised to inspect the outer package before use. Products should not be used if the outer package is opened or if the blister is torn or broken.

• It is important to check the end flap for the expiration date and lot number to ensure product validity.