OTC Medication Information: Acetaminophen
ACETAMINOPHEN- acetaminophen tablet, film coated, extended release
American Sales Company
ACTIVE INGREDIENT (IN EACH CAPLET)
PURPOSE
USES
- temporarily relieves minor aches and pains due to:
- minor pain of arthritis
- muscular aches
- backache
- headache
- toothache
- the common cold
- premenstrual and menstrual cramps
- 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 ▪ 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 doctorunder 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?
PRINCIPAL DISPLAY PANEL
Compare to the Active Ingredient in Tylenol ® Arthritis Pain †
Acetaminophen Extended-Release Tablets, USP 650 mg
For the Temporary Relief of Minor Arthritis Pain
DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN
DISTRIBUTED BY: AMERICAN SALES COMPANY
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Labeler — American Sales Company (809183973) |
Registrant — Ranbaxy Pharmaceuticals Inc. (937890044) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Ohm Laboratories Inc. | 184769029 | manufacture (41520-333) |
Revised: 01/2013 American Sales Company
Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.