PAIN RELIEVER- acetaminophen tablet, film coated

Pain Reliever by

Drug Labeling and Warnings

Pain Reliever by is a Otc medication manufactured, distributed, or labeled by WALGREENS, TIME CAP LABORATORIES, INC., MARKSANS PHARMA LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

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ACTIVE INGREDIENT

Active ingredient (in each caplet)

Acetaminophen 500 mg

PURPOSE

Purpose

Pain reliever/fever reducer

INDICATIONS & USAGE

Uses

• temporarily relieves minor aches and pains due to:

-the common cold
-headache
-backache
-minor pain of arthritis
-toothache
-muscular aches
-premenstrual and menstrual cramps

• temporarily reduces fever

WARNINGS

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.

DO NOT USE

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 DOCTOR

Ask a doctor before use if you have liver disease

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

STOP USE

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OVERDOSAGE

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

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, unless directed by a doctor

    do not use for more than 10 days unless directed by a doctor
  • children under 12 years:

    ask a doctor

OTHER SAFETY INFORMATION

Other information

store between 20-25ºC (68-77ºF)

INACTIVE INGREDIENT

Inactive ingredientscarnauba wax, FD&C red no. 40 al. lake, FD&C yellow no. 6 al. lake, guar gum, hypromellose, light mineral oil, maltodextrin, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

QUESTIONS

Questions or comments? Call 1-877-290-4008

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN RELIEVER 
acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-6779
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 6 ALUMINUM LAKE (UNII: GYP6Z2JR6Q)
GUAR GUM (UNII: E89I1637KE)
TALC (UNII: 7SEV7J4R1U)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
STARCH, CORN (UNII: O8232NY3SJ)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POVIDONE (UNII: FZ989GH94E)
FD&C RED NO. 40 ALUMINUM LAKE (UNII: 6T47AS764T)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
CARNAUBA WAX (UNII: R12CBM0EIZ)

Product Characteristics
Color	red	Score	no score
Shape	OVAL (Capsule shaped tablets)	Size	18mm
Flavor		Imprint Code	TCL341
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-6779-42	1 in 1 CARTON	02/01/2026
1		24 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 0363-6779-01	1 in 1 CARTON	02/01/2026
2		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	02/01/2026

Labeler - WALGREENS (008965063)

Registrant - TIME CAP LABORATORIES, INC. (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		925822975	manufacture(0363-6779)