PAIN RELIEVER FEVER REDUCER EXTRA STRENGTH- acetaminophen liquid

Pain Reliever fever Reducer by

Drug Labeling and Warnings

Pain Reliever fever Reducer by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 15 mL)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pains due to: 
  • the common cold
  • headache
  • backache
  • minor pain of arthritis
  • toothache 
  • muscular ache
  • premenstrual and menstrual cramps  
• temporarily reduces fever

Warnings

Liver warning:  This product contains acetaminophen. The maximum daily dose of this product is 90 mL (6 tbsp) (3,000 mg) in 24 hours. 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 ever 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.

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.

Ask a doctor before use if you have

liver disease.

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

• pain gets worse or lasts for more than 10 days
• fever gets worse or lasts for more than 3 days
• new symptoms occur
• redness or swelling is present

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 then 4 doses in any 24 hours 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 6 hours while symptoms last
  • do not take more than 10 days unless directed by a doctor
• children under 12 years: do not use 

Other information

• each 15 mL contains:sodium 6 mg 
• store between 20-25ºC (68-77ºF) do not refrigerate
• protect from light

Inactive ingredients

citric acid, D&C red 33, FD&C red 40, flavors, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol

Questions or comments?

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

Principal Display Panel

Compare to the active ingredient in Extra Strength Tylenol®*

EXTRA STRENGTH

Acetaminophen, Liquid 500 mg

Pain reliever; Fever reducer

For Ages 12 & over

Cherry flavor

FL OZ (mL)

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

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Extra Strength Tylenol®. 

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, PI 02895

CVS.com

Product Label

CVS HEALTH Extra Strength Acetaminophen Cherry Flavor

INGREDIENTS AND APPEARANCE

PAIN RELIEVER FEVER REDUCER  EXTRA STRENGTH
acetaminophen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-878
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-878-08	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/30/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	04/30/2018

Labeler - CVS Pharmacy (062312574)