ACETAMINOPHEN- acetaminophen tablet, film coated, extended release
Chain Drug Marketing Association Inc.
ACTIVE INGREDIENT (IN EACH CAPLET)
Acetaminophen USP, 650 mg
Pain reliever/fever reducer
- temporarily relieves minor aches and pains due to:
- muscular aches
- minor pain of arthritis
- temporarily reduces fever
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
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
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.
- 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 |
- 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.
Croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide
PRINCIPAL DISPLAY PANEL
QC QUALITY CHOICE ®
† Compare to the active ingredient in Tylenol ® 8 Hour
Lasts up to 8 HOUR
Use only as directed.
See New Warnings Information
DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN
EXTENDED-RELEASE TABLETS, USP 650 mg
Pain Reliever/Fever Reducer
For up to 8 Hour Relief of Minor Muscular Aches & Pain
50 CAPLETS * 650 mg EACH
( * capsule-shaped tablets)
©DISTRIBUTED BY QUALITY CHOICE
| ACETAMINOPHEN |
acetaminophen tablet, film coated, extended release
|Product Information |
|Product Type ||HUMAN OTC DRUG ||Item Code (Source) ||NDC:63868-091 |
|Route of Administration ||ORAL ||DEA Schedule || |
|Active Ingredient/Active Moiety |
|Ingredient Name ||Basis of Strength ||Strength |
|ACETAMINOPHEN (ACETAMINOPHEN) ||ACETAMINOPHEN ||650 mg |
|Inactive Ingredients |
|Ingredient Name ||Strength |
| CROSCARMELLOSE SODIUM || |
| HYPROMELLOSES || |
| MAGNESIUM STEARATE || |
| CELLULOSE, MICROCRYSTALLINE || |
| POVIDONE || |
| STARCH, PREGELATINIZED CORN || |
| PROPYLENE GLYCOL || |
| SODIUM LAURYL SULFATE || |
| STEARIC ACID || |
| TITANIUM DIOXIDE || |
|Product Characteristics |
|Color ||white ||Score ||no score |
|Shape ||OVAL (Capsule Shaped) ||Size ||19mm |
|Flavor || ||Imprint Code ||cor116 |
|Contains || |
|# ||Item Code ||Package Description ||Multilevel Packaging |
| 1 ||NDC:63868-091-50 ||50 TABLET, FILM COATED, EXTENDED RELEASE (TABLET) in 1 BOTTLE ||None |
| 2 ||NDC:63868-091-01 ||100 TABLET, FILM COATED, EXTENDED RELEASE (TABLET) in 1 BOTTLE ||None |
| Marketing Information |
|Marketing Category ||Application Number or Monograph Citation ||Marketing Start Date ||Marketing End Date |
|ANDA ||ANDA076200 ||04/30/2002 || |
|Labeler — Chain Drug Marketing Association Inc.
|Registrant — Ranbaxy Pharmaceuticals Inc. (937890044) |
| Establishment |
|Name ||Address ||ID/FEI ||Operations |
|Ohm Laboratories Inc. || ||184769029 ||manufacture (63868-091) |
Revised: 10/2012 Chain Drug Marketing Association Inc.