LEADER 8 HOUR PAIN RELIEVER — acetaminophen tablet, film coated, extended release
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
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)
a dults 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
c hildren under 12 years:
- store at 20 — 25° C (68 — 77° F). Avoid excessive heat 40° C (104° F).
- see end panel for batch number and expiration date
croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE. (for bottle cartons/label and stand-alone labels only)
THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN. (for non CRC packages)
Contains No Aspirin
Keep the carton. It contains important information.
DUBLIN, OHIO 43017
PRINCIPAL DISPLAY PANEL
Use only as directed.
Lasts up to 8 Hour Pain Reliever
Acetaminophen Extended-Release Tablets, USP 650 mg
Pain Reliever/Fever Reducer
For up to 8 Hour Relief of Minor Muscular Aches & Pain
DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN
THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN
100 CAPLETS* 650 mg EACH
Compare to Tylenol® 8 Hour active ingredient**
**This product is not manufactured or distributed by McNeil Consumer Healthcare, Inc. The owner of the registered trademark Tylenol® is The Tylenol Company.
100’s bottle carton
| LEADER 8 HOUR PAIN RELIEVER |
acetaminophen tablet, film coated, extended release
|Product Information |
|Product Type ||HUMAN OTC DRUG ||Item Code (Source) ||NDC:37205-477 |
|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 |
| HYPROMELLOSES || |
| CELLULOSE, MICROCRYSTALLINE || |
| STARCH, PREGELATINIZED CORN || |
| SODIUM LAURYL SULFATE || |
| MAGNESIUM STEARATE || |
| CROSCARMELLOSE SODIUM || |
| POVIDONE || |
| STEARIC ACID || |
| PROPYLENE GLYCOL || |
| 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:37205-477-78 ||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 — Cardinal Health
|Registrant — Ohm Laboratories Inc. (051565745) |
| Establishment |
|Name ||Address ||ID/FEI ||Operations |
|Ohm Laboratories Inc. || ||184769029 ||manufacture |
Revised: 03/2012 Cardinal Health