Label: ACETAMINOPHEN tablet, film coated, extended release
-
Contains inactivated NDC Code(s)
NDC Code(s): 55319-333-01, 55319-333-23 - Packager: Family Dollar Services, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated July 6, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each caplet)
- Purpose
- Uses
-
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
- •
- 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?
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 650 mg Caplet Bottle Carton
FAMILY
wellness™COMPARE TO
TYLENOL® ARTHRITIS PAIN*EASY
TO OPEN
BOTTLEUse only as directed.
NDC 55319-333-01ARTHRITIS
Pain Relief
Acetaminophen Extended-release Tablets USP, 650 mg
Pain Reliever/Fever Reducer- •
- For the Temporary Relief of Minor Arthritis Pain
Lasts up to
8 HoursDO NOT USE WITH OTHER
MEDICINES CONTAINING
ACETAMINOPHENACTUAL SIZE
THIS PACKAGE FOR
HOUSEHOLDS WITHOUT
YOUNG CHILDREN100% SATISFACTION
OR YOUR MONEY BACK
GUARANTEED100 CAPLETS* (*Capsule-Shaped Tablets)
-
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen tablet, film coated, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-333 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 HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) Product Characteristics Color white Score no score Shape OVAL (Capsule Shaped) Size 19mm Flavor Imprint Code cor116 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-333-23 24 in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2017 2 NDC:55319-333-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/30/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076200 09/01/2017 Labeler - Family Dollar Services, Inc. (024472631) Registrant - Ohm Laboratories Inc. (051565745) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 051565745 MANUFACTURE(55319-333)