OTC Medication Information: Acetaminophen
ACETAMINOPHEN- acetaminophen tablet, film coated, extended release
Chain Drug Marketing Association Inc.
ACTIVE INGREDIENT (IN EACH CAPLET)
PURPOSE
USES
- temporarily relieves minor aches and pains due to:
- muscular aches
- backache
- headache
- minor pain of arthritis
- temporarily reduces fever
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
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.
DIRECTIONS
- 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 doctorchildren under 12 years do not use
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?
PRINCIPAL DISPLAY PANEL
† Compare to the active ingredient in Tylenol ® 8 Hour
DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN
EXTENDED-RELEASE TABLETS, USP 650 mg
For up to 8 Hour Relief of Minor Muscular Aches & Pain
©DISTRIBUTED BY QUALITY CHOICE
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| Labeler — Chain Drug Marketing Association Inc. (011920774) |
| 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.
