acetaminophen by Bryant Ranch Prepack ACETAMINOPHEN tablet

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]

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

PRINCIPAL DISPLAY PANEL

Acetaminophen 500 mg Tablets

INGREDIENTS AND APPEARANCE

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

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)