OTC Medication Information: Pain Relief Extra Strength

PAIN RELIEF EXTRA STRENGTH- acetaminophen liquid
EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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 or arthritis
    • toothache
    • muscular aches
    • premenstrual and menstrual cramps
  • 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 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 1-888-287-1915

Principal Display Panel

Compare to Tylenol® Extra Strength Active Ingredient*

Adult Extra Strength

Pain Reliever

Acetaminophen 500 mg per 15 mL

Pain reliever, fever reducer

  • For ages 12 years and over
  • Alcohol free

CHERRY FLAVOR

FL OZ (mL)

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

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

DISTRIBUTED BY: Wal-Mart Inc.,

Bentonville, AR 72716

Product Label

Acetaminophen 500 mg
(click image for full-size original)

EQUATE Pain Reliever Extra Strength Cherry Flavor

PAIN RELIEF EXTRA STRENGTH
acetaminophen liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-278
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg in 15 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
D&C RED NO. 33
FD&C RED NO. 40
HIGH FRUCTOSE CORN SYRUP
POLYETHYLENE GLYCOL, UNSPECIFIED
PROPYLENE GLYCOL
WATER
SACCHARIN SODIUM
SODIUM BENZOATE
SORBITOL
Product Characteristics
Color Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49035-278-08 237 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 12/31/2015
Labeler — EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) (051957769)

Revised: 12/2022 EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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