[NCS HealthCare of KY, Inc dba Vangard Labs]
|Category||DEA Schedule||Marketing Status|
|HUMAN OTC DRUG LABEL||OTC monograph final|
for the temporary relief of minor aches and pains due to: Headache, Muscular aches, Backache, Minor pain of arthritis, The common cold, Toothache, Premenstrual and menstrual cramps.
Temporarily reduces fever.
This product contains acetaminophen.
The maximum daily dose of this product is 6 tablets (3,000mg) in 24 hours. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
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.
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.
Overdose Warning: Taking more than the recommended dose ( overdose) may cause liver damage. In the 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 the directed (see overdose warning)
Adults and children 12 years and over:
- Take 2 tablets every 6 hours while symptoms last.
- Do not take more than 6 tablets in 24 hours unless directed by a doctor
- Do not take for more than 10 days unless directed by a doctor
Children under 12 years: Do not use adult Extra Strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.
Do not use if imprinted safety seal under cap is broken or missing.
Store at room temperature
To Report Adverse Drug Event call (800) 616-2471
Dist. By MAJOR PHARMACEUTICALS
31778 Enterprise Drive. Livonia, MI 48150
|Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)|
|NCS HealthCare of KY, Inc dba Vangard Labs||050052943||RELABEL(0615-4510), REPACK(0615-4510)|