FLU, COUGH AND SORE THROAT- acetaminophen, diphenhydramine hcl, phenylephrine hcl liquid

Flu, Cough and Sore Throat by

Drug Labeling and Warnings

Flu, Cough and Sore Throat by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 30 mL)

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 10 mg

Purpose

Pain reliever/fever reducer

Antihistamine/

Cough suppressant

Nasal decongestant

Uses

• temporarily relieves these symptoms due to a cold/flu
  • minor aches and pains
  • headache
  • sore throat
  • runny nose
  • sneezing
  • 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

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
• 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
• high blood pressure
• heart disease
• diabetes
• thyroid disease
• a breathing problem such as emphysema or chronic bronchitis 
• trouble urinating due to an enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• 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 alcoholic 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 occurs
• 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 conditons

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 (180mg) 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 14mg
• 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

Questions or comments?

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

Principal Display Panel

Flu, Cough & Sore Throat

ACETAMINOPHEN

Pain reliever; Fever reducer

DIPHENHYDRAMINE HCl

Cough suppressant; Antihistamine

PHENYLEPHRINE HCl

Nasal decongestant

Relief of:

Nasal congestion;

Runny nose; Cough;

Body ache; Sore throat;

Headache; fever

Berry Flavor

Alcohol content 10 %

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

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

CVS.com® 1-800-SHOP CVS

Product Label

CVS Health Flu, Cough & Sore Throat Berry Flavor

INGREDIENTS AND APPEARANCE

FLU, COUGH AND SORE THROAT 
acetaminophen, diphenhydramine hcl, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-653
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 30 mL
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg  in 30 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ALCOHOL (UNII: 3K9958V90M)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
MALTITOL (UNII: D65DG142WK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)

Product Characteristics
Color		Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-653-08	245 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/30/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	09/30/2016

Labeler - CVS Pharmacy (062312574)