Major Pharmaceuticals Acetaminophen Drug Facts

acetaminophen by

Drug Labeling and Warnings

acetaminophen by is a Otc medication manufactured, distributed, or labeled by Bryant Ranch Prepack. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACETAMINOPHEN- acetaminophen tablet 
Bryant Ranch Prepack

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Major Pharmaceuticals Acetaminophen Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pains due to:
  • headache
  • muscular aches
  • backache
  • toothache
  • minor pain of arthritis
  • the common cold
  • 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 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

• 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 have ever had an allergic reaction to this product or any of its ingredients

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 (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.

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

Inactive ingredients

carnauba wax, corn starch*, croscarmellose sodium*, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid

*may contain one or more of these ingredients

Questions or comments?

1-800-719-9260

HOW SUPPLIED

Acetaminophen 500 mg Tablet

• NDC: 71335-9644-1: 20 Tablets in a BOTTLE
• NDC: 71335-9644-2: 15 Tablets in a BOTTLE
• NDC: 71335-9644-3: 40 Tablets in a BOTTLE
• NDC: 71335-9644-4: 100 Tablets in a BOTTLE
• NDC: 71335-9644-5: 30 Tablets in a BOTTLE
• NDC: 71335-9644-6: 45 Tablets in a BOTTLE
• NDC: 71335-9644-7: 50 Tablets in a BOTTLE
• NDC: 71335-9644-8: 60 Tablets in a BOTTLE
• NDC: 71335-9644-9: 90 Tablets in a BOTTLE
• NDC: 71335-9644-0: 250 Tablets in a BOTTLE

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504

Acetaminophen 500 mg Tablets

ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71335-9644(NDC: 0904-6720)
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
CARNAUBA WAX (UNII: R12CBM0EIZ)
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	L484
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71335-9644-1	20 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2024
2	NDC: 71335-9644-2	15 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2024
3	NDC: 71335-9644-3	40 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2024
4	NDC: 71335-9644-4	100 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2024
5	NDC: 71335-9644-5	30 in 1 BOTTLE; Type 0: Not a Combination Product	04/17/2023
6	NDC: 71335-9644-6	45 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2024
7	NDC: 71335-9644-7	50 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2024
8	NDC: 71335-9644-8	60 in 1 BOTTLE; Type 0: Not a Combination Product	03/14/2023
9	NDC: 71335-9644-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2024
10	NDC: 71335-9644-0	250 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	07/26/2018	05/16/2025

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Business Operations
Bryant Ranch Prepack		171714327	repack(71335-9644) , relabel(71335-9644)

Revised: 5/2025

Document Id: 3545e589-6377-cd17-e063-6394a90a625e

34390-5

Set id: 4c6e250e-1eef-4b55-ab27-c14a4c26f42c

Version: 104

Effective Time: 20250516