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NDC 49035-0494-24 Pain Reliever 500 mg/1 Details

Pain Reliever 500 mg/1

Pain Reliever is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC). The primary component is ACETAMINOPHEN.

MedlinePlus Drug Summary

Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Related Packages: 49035-0494-24
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	49035-0494
Product ID	49035-494_492c57f6-bff2-4d15-83a1-94c9e8c282bb
Associated GPIs	64200010000315
GCN Sequence Number	004490
GCN Sequence Number Description	acetaminophen TABLET 500 MG ORAL
HIC3	H3E
HIC3 Description	ANALGESIC/ANTIPYRETICS,NON-SALICYLATE
GCN	16965
HICL Sequence Number	001866
HICL Sequence Number Description	ACETAMINOPHEN
Brand/Generic	Generic
Proprietary Name	Pain Reliever
Proprietary Name Suffix	Extra Strength
Non-Proprietary Name	Acetaminophen
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	500
Active Ingredient Units	mg/1
Substance Name	ACETAMINOPHEN
Labeler Name	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part343
Listing Certified Through	n/a

Package

Package Images

NDC 49035-0494-24 (49035049424)

Pricing Information	N/A
NDC Package Code	49035-494-24
Billing NDC	49035049424
Package	1 BOTTLE, PLASTIC in 1 BOX (49035-494-24) / 24 TABLET in 1 BOTTLE, PLASTIC
Marketing Start Date	2014-05-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 9f20fe6d-2e58-47e2-a08d-da926694518e Details

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to
- headache
- the common cold
- backache
- minor arthritis pain
- 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.
if you are allergic to acetaminophen or any of the inactive ingredients in this product

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 more than 10 days
fever gets worse or lasts 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: In case of overdose, get medical help or contact a Poison Control Center 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)
adults and children 12 years and over
- take 2 caplets every 6 hours while symptoms last
- do not take more than 6 caplets in 24 hours
- do not take for more than 10 days unless directed by a doctor
children under 12 years: do not use

Other information

store between 20-25°C (68-77°F)

Inactive ingredients

corn starch, croscarmellose sodium*, hypromellose*, lactose monohydrate*, magnesium stearate*, maltodextrin*, medium-chain triglycerides*, mineral oil*, polydextrose*, polyethylene glycol*, polyvinyl alcohol*, povidone, purified water*, sodium starch glycolate*, stearic acid*, talc*, titanium dioxide

*contains one or more of these ingredients

Questions or comments?

Call 1-888-287-1915

Principal Display Panel

Compare to Tylenol® Extra Strength Active Ingredient†

EXTRA STRENGTH

Pain Reliever

Acetaminophen 500 mg

Pain reliever/Fever reducer

CAPLETS

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

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

DISTRIBUTED BY:

Wal-Mart Inc.,

Bentonville, AR 72716

Product Label

EQUATE Extra Strength Pain Reliever

INGREDIENTS AND APPEARANCE

PAIN RELIEVER EXTRA STRENGTH

acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-494
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MINERAL OIL (UNII: T5L8T28FGP)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POVIDONE (UNII: FZ989GH94E)
WATER (UNII: 059QF0KO0R)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	TCL341;AV;0821;P500
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49035-494-24	1 in 1 BOX	05/01/2014	01/31/2025
1		24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:49035-494-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2014	01/31/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	05/01/2014	01/31/2025

Labeler - EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) (051957769)

Revised: 10/2022

Document Id: 492c57f6-bff2-4d15-83a1-94c9e8c282bb

Set id: 9f20fe6d-2e58-47e2-a08d-da926694518e

Version: 5

Effective Time: 20221025