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

Flu and Sore Throat by

Drug Labeling and Warnings

Flu 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

Purposes

Pain reliever/fever reducer

Antihistamine/Cough suppressant

Nasal decongestant

Uses

• for the temporary relief of the following cold/flu symptoms
  • minor aches and pains
  • headache
  • runny nose
  • sneezing
  • itching od the nose or throat
  • sore throat
  • nasal and sinus congestion
  • itchy, watery eyes
• temporarily reduces fever 

Warnings

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. 

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

• more than 6 doses (12 tablespoons or 180 mL) in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

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 product 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 accompanied by excessive 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 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 occur
• pain 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 us present

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) immediately. 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 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 at 20-25ºC (68-77ºF). do not refrigerate

Inactive ingredients

acesulfame potassium, alcohol, citric acid, disodium EDTA, 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 & Sore Throat

Acetaminophen

Pain reliever; fever reducer

Diphenhydramine HCl

Antihistamine

Phenylephrine HCl

Nasal decongestant

Relief of:

Nasal congestion

Runny nose

Body ache

Sore throat

Headache

Fever

Cherry flavor

Alcohol 10 %

for ages 12 & over

FL OZ (mL)

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 Flu and Sore Throat

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-938
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	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-938-08	245 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/31/2015	12/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	05/31/2015	12/31/2021

Labeler - CVS Pharmacy (062312574)