Label: ACETAMINOPHEN- acetaminophen tablet extended release tablet, extended release
-
NDC Code(s):
71335-9746-1,
71335-9746-2,
71335-9746-3,
71335-9746-4, view more71335-9746-5, 71335-9746-6, 71335-9746-7
- Packager: Bryant Ranch Prepack
- This is a repackaged label.
- Source NDC Code(s): 49483-699
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 5, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
-
INDICATIONS & USAGE
Uses
For Arthritis Pain
temporarily relieves minor aches and pains due to:
- minor pain of arthritis
- muscular aches
- backache
- premenstrual and menstrual cramps
- the common cold
- headache
- toothache
temporarily reduces fever
For Muscle Aches & Pains
temporarily relieves minor aches and pains due to:
- muscular aches
- backache
- minor pain of arthritis
- toothache
- premenstrual and menstrual cramps
- headache
- the common cold
temporarily reduces fever
-
WARNINGS
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 6 caplets in 24 hours, which is the maximum daily amount
- 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
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
For Arthritis Pain
Do not take more than directed. See overdose warning
adults:
- take 2 caplets every 8 hours with water
- swallow whole; do not crush, chew, split or dissolve
- do not take more than 6 caplets in 24 hours
- do not use for more than 10 days unless directed by a doctor
under 18 years of age: ask a doctor
For Muscle Aches & Pains
Do not take more than directed. See overdose warning
adults and children 12 years and over:
- take 2 caplets every 8 hours with water
- swallow whole; do not crush, chew, split or dissolve
- do not take more than 6 caplets in 24 hours
- do not use for more than 10 days unless directed by a doctor
children under 12 years: do not use
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
-
HOW SUPPLIED
Acetaminophen Extended-Release 650 mg Tablet
- NDC 71335-9746-1: 30 Tablets in a BOTTLE
- NDC 71335-9746-2: 100 Tablets in a BOTTLE
- NDC 71335-9746-3: 50 Tablets in a BOTTLE
- NDC 71335-9746-4: 60 Tablets in a BOTTLE
- NDC 71335-9746-5: 120 Tablets in a BOTTLE
- NDC 71335-9746-6: 19 Tablets in a BOTTLE
- NDC 71335-9746-7: 20 Tablets in a BOTTLE
Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504 - PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen tablet extended release tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71335-9746(NDC:49483-699) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) POVIDONE K30 (UNII: U725QWY32X) MAGNESIUM STEARATE (UNII: 70097M6I30) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) TRIACETIN (UNII: XHX3C3X673) CARNAUBA WAX (UNII: R12CBM0EIZ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5) Product Characteristics Color white (White to off white) Score no score Shape CAPSULE Size 19mm Flavor Imprint Code 71 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71335-9746-1 30 in 1 BOTTLE; Type 0: Not a Combination Product 11/16/2023 2 NDC:71335-9746-2 100 in 1 BOTTLE; Type 0: Not a Combination Product 04/05/2024 3 NDC:71335-9746-3 50 in 1 BOTTLE; Type 0: Not a Combination Product 04/05/2024 4 NDC:71335-9746-4 60 in 1 BOTTLE; Type 0: Not a Combination Product 04/05/2024 5 NDC:71335-9746-5 120 in 1 BOTTLE; Type 0: Not a Combination Product 04/05/2024 6 NDC:71335-9746-6 19 in 1 BOTTLE; Type 0: Not a Combination Product 04/05/2024 7 NDC:71335-9746-7 20 in 1 BOTTLE; Type 0: Not a Combination Product 04/05/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA215486 10/04/2021 Labeler - Bryant Ranch Prepack (171714327) Registrant - Bryant Ranch Prepack (171714327) Establishment Name Address ID/FEI Business Operations Bryant Ranch Prepack 171714327 REPACK(71335-9746) , RELABEL(71335-9746)