Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 0a205049-811f-4f66-ac29-cb2a7b4efbf0
Route
ORAL
Published
Effective Date 2014-02-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (250 mg) Chlorpheniramine (2 mg)
Inactive Ingredients
Caffeine Cochineal Starch, Corn Fd&c Yellow No. 5 Fd&c Blue No. 1 Hydroxymethyl Cellulose Sucrose

Identifiers & Packaging

Pill Appearance
Shape: capsule Size: 20 mm
Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-01-30

Description

Acetaminophen 250 mg Chlorpheniramine Maleate 2 mg

Purpose

Pain reliever Antihistamine


Medication Information

Purpose

Pain reliever

Antihistamine

Description

Acetaminophen 250 mg Chlorpheniramine Maleate 2 mg

Uses

■temporarily relieves these symptoms of hay fever and other upper respiratory allergies: 

■runny nose and sneezing ■itchy, watery eyes

■temporarily relieves these additional symptoms of hay fever or other respiratory allergies:

■headache ■minor aches and pains

Warnings

Liver warning This product contains acetaminophen. The maximum daily dose of this product is 12 capsules in 24 hours. Severe liver damage many occur if you take ■ more than 4,000 mg of acetaminophen in 24 hours ■with other drugs containing acetaminophen ■3 or more alcoholic drinks daily while using this product.

Directions

■ do not take more than directed (see Liver warning)

adults and children 12 years of age and over

■ take 2 caplets every 4 hours. ■swallow whole-do not crush, chew dissolve 

■ do not take more than 12 capsules in 24 hours. ■ children under 12 years ask a doctor

Do Not Use

■with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist.

■if you have ever had an allergic reactionto this product or any of its ingredients

■to make a child sleepy

Package Label

Inactive Ingredients

Caffeine, Carmine, Corn Starch, FDC Yellow 5, FDC Blue 1,hydroxy methylcellulose, Sugar

When Using This Product

do not exceed recommended dosage

■ drowsiness may occur ■alcohol, sedatives and tranquilizers may increase drowsiness

■ avoid alcoholic drinks ■be careful when driving a motor vehicle or operating machinery

■ excitability may occur, especially in children

Stop Use and Ask A Doctor If

■ nervousness, dizziness, or sleepleessness occur ■ pain 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

This could be signs of a serious condition

Keep Out of Reach of Children

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

If pregnant Or Breast Feeding

ask a health professional before

Active Ingredient (in Each Capsule)

Acetaminophen 250 mg

Chlorpheniramine Maleate 2 mg

Ask A Doctor Before Use If You Have

■ liver disease ■ trouble urinating due to an enlarged prostate gland

■ a breathing problem such as emphysema or chronic bronchitis ■ Glaucoma

Ask A Doctor Or Pharmacist If You Are

■ taking the blood thinner drug, warfarin

■ taking sedatives or tranquilizers


Structured Label Content

Uses

■temporarily relieves these symptoms of hay fever and other upper respiratory allergies: 

■runny nose and sneezing ■itchy, watery eyes

■temporarily relieves these additional symptoms of hay fever or other respiratory allergies:

■headache ■minor aches and pains

Purpose

Pain reliever

Antihistamine

Warnings

Liver warning This product contains acetaminophen. The maximum daily dose of this product is 12 capsules in 24 hours. Severe liver damage many occur if you take ■ more than 4,000 mg of acetaminophen in 24 hours ■with other drugs containing acetaminophen ■3 or more alcoholic drinks daily while using this product.

Directions

■ do not take more than directed (see Liver warning)

adults and children 12 years of age and over

■ take 2 caplets every 4 hours. ■swallow whole-do not crush, chew dissolve 

■ do not take more than 12 capsules in 24 hours. ■ children under 12 years ask a doctor

Do Not Use (Do not use)

■with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist.

■if you have ever had an allergic reactionto this product or any of its ingredients

■to make a child sleepy

Package Label

Inactive Ingredients (Inactive ingredients)

Caffeine, Carmine, Corn Starch, FDC Yellow 5, FDC Blue 1,hydroxy methylcellulose, Sugar

When Using This Product (When using this product)

do not exceed recommended dosage

■ drowsiness may occur ■alcohol, sedatives and tranquilizers may increase drowsiness

■ avoid alcoholic drinks ■be careful when driving a motor vehicle or operating machinery

■ excitability may occur, especially in children

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

■ nervousness, dizziness, or sleepleessness occur ■ pain 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

This could be signs of a serious condition

Keep Out of Reach of Children (Keep out of reach of children)

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

If pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health professional before

Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))

Acetaminophen 250 mg

Chlorpheniramine Maleate 2 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

■ liver disease ■ trouble urinating due to an enlarged prostate gland

■ a breathing problem such as emphysema or chronic bronchitis ■ Glaucoma

Ask A Doctor Or Pharmacist If You Are (Ask a doctor or pharmacist if you are)

■ taking the blood thinner drug, warfarin

■ taking sedatives or tranquilizers


Advanced Ingredient Data


Raw Label Data

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