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FDA LABEL GENERIC: Acetaminophen MFR: P & L Development, LLC

Apap 21.7 Mg/ml / Diphenhydramine Hydrochloride 0.833 Mg/ml / Phenylephrine Hydrochloride 0.333 Mg/ml Oral Solution

Table of Contents

Active ingredients (in each 30 mL)
Purposes
Uses
Warnings
Directions
Other information
Inactive ingredients
Product Label

Active ingredients (in each 30 mL)

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 10 mg

Purposes

Pain reliever/fever reducer

Antihistamine/Cough suppressant

Nasal decongestant

Uses

temporarily relieves there symptoms due to a cold minor aches and pains headache sore throat runny nose sneezing itchy, watery eyes due to hay fever nasal and sinus congestion itching of the nose or throat cough due to minor throat and bronchial irritation temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 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

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 if you are 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. with any other product containing diphenhydramine, even one used on skin with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have

liver disease glaucoma heart disease thyroid disease high blood pressure diabetes cough that occurs with too much phlegm (mucus) trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are taking

the blood thinning drug warfarin sedatives or tranquilizers

When using this product

do not exceed recommended dosage alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcohol drinks be careful when driving a motor vehicle or operating machinery marked drowsiness may occur excitability may occur, especially in children

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occur pain, cough or nasal congestion gets worse or lasts more than 7 days new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present 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 (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.

Directions

do not take more than directed (see overdose warning) do not take more than 6 doses (180 mL) in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device mL=milliliter keep dosing cup with product adults and children 12 years and over 30 mL every 4 hours children under 12 years of age; do not use

Other information

each 30 mL contains: potassium 10 mg each 30 mL contains: sodium 14 mg store between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive ingredients

acesulfame potassium, alcohol, citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavors, glycerin, maltitol, propylene glycol, purified water, sodium benzoate, sodium citrate

Principal Display Panel

Compare to the active ingredients in Theraflu® ExpressMax® Nighttime Severe Cold & Cough *

adult nighttime Severe Cold & Cough relief

Acetaminophen 650 mg

Pain reliever/Fever reducer

Diphenhydramine HCl 25 mg

Antihistamine/Cough Suppressant

Phenylephrine HCl 10 mg

Nasal decongestant

relieves:

Nasal Congestion runny nose cough sore throat body ache Fever headache

for ages 12 years & older

alcohol 10%

berry flavor

FL OZ (mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.

*This product is not manufactured or distributed by GSK Consumer Health, distributor Theraflu® ExpressMax® Nighttime Severe Cold & Cough.

Manufactured by: PL Developments

11865 S. Alameda ST

Lynwood, CA 90262

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST