Label: ACETAMINOPHEN tablet, extended release
-
Contains inactivated NDC Code(s)
NDC Code(s): 37808-333-01, 37808-333-50 - Packager: H-E-B
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 30, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT (IN EACH CAPLET)
- PURPOSE
- USES
-
WARNINGS
Liver warning: This product contains acetaminophen. Sever 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
- •
- 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.
-
DIRECTIONS
- •
- 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
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
-
PRINCIPAL DISPLAY PANEL
Compare to Tylenol® Arthritis Pain the active ingredient**
H-E-B®
ARTHRITIS PAIN RELIEF
acetaminophen
Extended-Release Tablets, USP 650 mg
Pain Reliever/Fever Reducer
Lasts up to 8 hrs
• For the Temporary Relief of Minor Arthritis Pain
DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN
See New Warning
Use only as directed.
50 CAPLETS*
(*Capsule-Shaped Tablets)
-
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-333 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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONES (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color WHITE Score no score Shape CAPSULE Size 19mm Flavor Imprint Code Cor116 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37808-333-50 1 in 1 CARTON 10/24/2005 1 50 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:37808-333-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 10/24/2005 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076200 04/30/2002 Labeler - H-E-B (007924756) Registrant - Ranbaxy Pharmaceuticals Inc. (937890044) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 184769029 MANUFACTURE(37808-333)