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FDA LABEL GENERIC: Acetaminophen MFR: Reckitt Benckiser LLC

Apap 162.5 Mg / Dextromethorphan Hydrobromide 5 Mg / Doxylamine Succinate 3.125 Mg Chewable Tablet

Drug Facts

Acetaminophen 162.5 mg

Dextromethorphan HBr 5 mg

Doxylamine succinate 3.125 mg

Acetaminophen 162.5 mg................................................Pain reliever/fever reducer

Dextromethorphan HBr 5 mg.......................... ...............Cough suppressant
Doxylamine succinate 3.125 mg.................................................Antihistamine

Uses

■ temporarily relieves these common cold and flu symptoms:

■ minor aches and pains

■ sore throat

■ headache
■ cough due to minor throat and bronchial irritation as may occur with
the common cold or inhaled irritants
■ runny nose

■ sneezing
■ temporarily reduces fever
■ controls cough to help the user get to sleep

WARNINGS

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage
may occur if:
■ adult takes more than 6 doses (24 chewable tablets) in 24 hours, which is
the maximum daily amount
■ child takes more than 5 doses (10 chewable tablets) in 24 hours, which is
the maximum daily amount
■ taken with other drugs containing acetaminophen
■ 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


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,
is accompanied or followed by fever, headache, rash, nausea, or vomiting,
consult a doctor promptly.


Do not use
■ to make a child sleepy
■ 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 the user is now 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
you do not know if your prescription drug contains an MAOI, ask a doctor
or pharmacist before taking this product.

Ask a doctor before use if you have
■ has liver disease
■ has a sodium-restricted diet
■ has glaucoma
■ has a breathing problem such as emphysema or chronic bronchitis
■ has difficulty in urination due to enlargement of the prostate gland
■ is a child with pain of arthritis

Ask a doctor or pharmacist before use if you are
■ taking the blood thinning drug warfarin
■ taking sedatives or tranquilizers

When using this product
■ do not use more than directed (see Overdose warning)
■ excitability may occur, especially in children
■ marked drowsiness may occur
■ alcohol, sedatives, and tranquilizers may increase the drowsiness effect
■ avoid alcoholic beverages
■ use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if
■ pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
■ 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.

If pregnant or breast-feeding, ask a health professional before use.


Keep out of reach of children.


Overdose warning: Taking more than the recommended dose (overdose) may
cause liver damage. In case of 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 you do not notice any signs or symptoms.

DOSAGE AND ADMINISTRATION

Directions
■ do not take more than directed (see Overdose warning)
■ chew thoroughly before swallowing
■ dose every 4 hours or as directed by a doctor

adults and children 12 years
of age and over
4 chewable tablets every 4 hours, not to exceed
6 doses (24 chewable tablets) in any 24-hour period
children 6 to under 12 years
of age
2 chewable tablets every 4 hours, not to exceed
5 doses (10 chewable tablets) in any 24-hour period
children under 6 years of age do not use

Other information
■ each chewable tablet contains: potassium 5 mg and sodium 13 mg
■ Store in a cool dry place at 20-25°C (68-77°F)

Inactive ingredients

anhydrous citric acid, corn syrup, ethylcellulose, FD&C blue no. 1, FD&C red no. 40,
flavor, glycerin, malic acid, maltodextrin, pectin, potassium sodium tartrate,
purified water, sodium chloride, sodium polymetaphosphate, sucralose,
sucrose, trisodium citrate (anhydrous)

Questions? 1-866-MUCINEX (1-866-682-4639)

ASK A DOCTOR

NDC 72854-085-16

Children's
Mucinex®

Cough Suppressant

Antihistamine

Acetaminophen 162.5 mg

Dextromethorphan HBr 5 mg

Doxylamine succinate 3.125 m

Age 6+

Mixed Berry Flavor