FDA LABEL GENERIC: Acetaminophen MFR: CVS PHARMACY

Apap 160 Mg / Dextromethorphan Hydrobromide 5 Mg Per 5 Ml Oral Suspension

Table of Contents

Uses
Warnings
Directions
Other information
Inactive ingredients
Questions or comments?

Drug Facts

Active ingredients (in each 5 mL)	Purposes
Acetaminophen 160 mg	Pain reliever/fever reducer
Dextromethorphan HBr 5 mg	Cough suppressant

Uses

temporarily relieves the following cold/flu symptoms: minor aches and pains headache sore throat cough temporarily reduces fever

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if your child takes

more than 5 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen

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

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. if your child has ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if your child has

liver disease persistent or chronic cough such as occurs with asthma cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if your child istaking the blood thinning drug warfarin

When using this product

do not exceed recommended dose (see overdose warning )

Stop use and ask a doctor if

pain or cough gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present cough comes back or occurs with rash or headache that lasts

These could be signs of a serious condition.

Keep out of reach of children.

Overdose warning

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

Directions

this product does not contain directions or complete warnings for adult use do not give more than directed (see overdose warning ) shake well before using mL = milliliter find the right dose on chart below. If possible, use weight to dose; otherwise, use age. remove the child protective cap and squeeze your child's dose into the dosing cup repeat dose every 4 hours, while symptoms last do not give more than 5 times in 24 hours

Weight (lb)	Age (yr)	Dose (mL)
under 36	under 4 years	do not use
36-47	4 to 5 years	5 mL
48-95	6 to 11 years	10 mL

Attention:use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information

each 5 mL contains:sodium 3 mg store at room temperature

Inactive ingredients

carboxymethylcellulose sodium, anhydrous citric acid, D&C red no. 33, disodium edetate, FD&C red no. 40, flavors, glycerin, microcrystalline cellulose, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol solution, sucralose, xanthan gum

Questions or comments?

1-866-467-2748

PRINCIPAL DISPLAY PANEL

Compare to the active ingredients in Children’s Tylenol® Cold + Cough + Sore Throat*

NDC 51316-650-04

Children's

Cold + Cough

+ Sore Throat Relief

Acetaminophen,Pain Reliever-Fever Reducer
Dextromethorphan HBr, Cough Suppressant

Oral Suspension

Ages 4-11 Years

Fever Sore Throat Cough

Ibuprofen free, aspirin free,

No added alcohol

Bubblegum Flavor

Naturally and Artificially Flavored

4 FL OZ (120 mL)

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc, distributor of Children’s Tylenol® Cold + Cough + Sore Throat.

TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAPS IS TORN OR MISSING.