NDC | 67046-027-30, 67046-027-60, 67046-027-62 |
Set ID | b74b720d-3692-44f1-ab40-55ff612a95a6 |
Category | HUMAN OTC DRUG LABEL |
Packager | Contract Pharmacy Services-PA |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART343 |
- DRUG FACTS
- ACTIVE INGREDIENT (IN EACH CAPLET)
- PURPOSE
- USES
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WARNINGS
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 tablets 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
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.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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.
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DIRECTIONS
adults and children
12 years and over- take 2 tablets every 4 to 6 hours while symptoms last
- do not take more than 8 tablets in 24 hours
- do not take for more than 10 days unless directed by a doctor
do not use adult Extra Strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage - OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- Package Label
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INGREDIENTS AND APPEARANCE
EXTRA STRENGTH ACETAMINOPHEN
extra strength acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67046-027(NDC:10135-144) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Product Characteristics Color WHITE Score no score Shape OVAL ((capsule-shaped)) Size 17mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67046-027-30 30 in 1 BLISTER PACK 2 NDC:67046-027-60 60 in 1 BLISTER PACK 3 NDC:67046-027-62 60 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 08/02/2010 Labeler - Contract Pharmacy Services-PA (945429777)