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- NDC Code(s): 63941-333-01, 63941-333-50
- Packager: Valu Merchandisers Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 30, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
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- SPL UNCLASSIFIED SECTION
Drug Facts
- Active ingredient (in each caplet)
Acetaminophen USP, 650 mg
- Purpose
Pain reliever/fever reducer
- Uses
- 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
- temporarily relieves minor aches and pains due to:
- 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.
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 - 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
- store at 20 - 25° C (68 - 77° F). Avoid excessive heat 40° C (104° F).
- see end panel for batch number and expiration date
- TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
- Inactive ingredients
croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide
- Questions?
call 1-800-406-7984
- SPL UNCLASSIFIED SECTION
PROUDLY DISTRIBUTED BY:
VALU MERCHANDISERS, CO.
5000 KANSAS AVE
KANSAS CITY, KS 66106 - PRINCIPAL DISPLAY PANEL - 650 mg Caplet Bottle Carton
COMPARE TO THE ACTIVE INGREDIENT OF TYLENOL® ARTHRITIS PAIN**
Best
Choice®ARTHRITIS
Pain ReliefACTUAL SIZE
Use Only as Directed.
Last up to 8 Hours
Easy to Open Bottle
ACETAMINOPHEN
Extended-release Tablets USP, 650 mg
Pain Reliever/Fever Reducer
For the Temporary Relief of Minor Arthritis Pain100 CAPLETS*
(*CAPSULE-SHAPED TABLETS)THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN
DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN
- INGREDIENTS AND APPEARANCE
ACETAMINOPHEN - APAP ARTHRITIS
acetaminophen tablet, film coated, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63941-333 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) 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) 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:63941-333-50 50 in 1 BOTTLE; Type 0: Not a Combination Product 04/30/2002 2 NDC:63941-333-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 04/30/2002 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076200 04/30/2002 Labeler -Valu Merchandisers Company(868703513)
Registrant -Sun Pharmaceutical Industries Inc. (146974886)
Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 184769029 manufacture(63941-333)
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More Info on this Drug
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View Labeling Archives for this drug
ACETAMINOPHEN - APAP ARTHRITIS- acetaminophen tablet, film coated, extended release
Number of versions: 2
| Published Date (What is this?) | Version | Files |
|---|---|---|
| Jan 2, 2020 | 2 (current) | download |
| Feb 20, 2013 | 1 | download |
RxNorm
ACETAMINOPHEN - APAP ARTHRITIS- acetaminophen tablet, film coated, extended release
| RxCUI | RxNorm NAME | RxTTY | |
|---|---|---|---|
| 1 | 1148399 | acetaminophen 650 MG 8HR Extended Release Oral Tablet | PSN |
| 2 | 1148399 | 8 HR acetaminophen 650 MG Extended Release Oral Tablet | SCD |
| 3 | 1148399 | 8 HR APAP 650 MG Extended Release Oral Tablet | SY |
| 4 | 1148399 | acetaminophen 650 MG 8 HR Extended Release Oral Tablet | SY |
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NDC Codes
ACETAMINOPHEN - APAP ARTHRITIS- acetaminophen tablet, film coated, extended release
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
| NDC | |
|---|---|
| 1 | 63941-333-01 |
| 2 | 63941-333-50 |
