APAP
-
acetaminophen solution
Contract Pharmacal Corp
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Uses
- temporarily relieves minor aches and pains due to
- the common cold
- headache
- toothache
- muscular aches
- backache
- minor pain of arthritis
- menstrual cramps
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
- adults take more than 12 tablets in 24 hours, which is the maximum daily amount
- child take more than 5 doses in 24 hours
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
Do not use
- with any other product 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 other inactive ingredients in this products
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin
*This product is not manufactured or distributed by McNeil Consumer Heathcare, owner of the registered trademark Regular Strength Tylenol®
Manufactured by:
Contract Pharmacal Corp.
Hauppauge, NY 11788 USA
www.CPCHealth.com
Rev. 05/10
Drug Facts (continued)
Stop use and ask a doctor if
- pain gets worse or lasts for more than 10 days in adults and children
- pain gets worse or lasts for more than 5 days in children under 12 years
- 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 Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical for adults as well as 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 of age and over | take 2 tablets every 4 to 6 hours; not to exceed 12 tablets in 24 hours |
| children 6-11 years of age | take 1 tablets every 4 to 6 hours; not to exceed 5 tablets in 24 hours |
| children under 6 years of age | Do not use adult Regular Strength product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage |
DO NOT EXCEED RECOMMENDED DOSE
Other information
- store at controlled room temperature, USP
- side effects occur. You may report side effects to the FDA at 1-800-FDA-1088 (Toll Free).
Inactive ingredients
Polyvinylpyrrolodone, Pregelatinized Starch, Sodium Starch Glycolate and Stearic Acid.
| APAP
acetaminophen solution |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph not final | part343 | 05/29/2001 | |
| Labeler - Contract Pharmacal Corp (968334974) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Contract Pharmacal Corp | 968334974 | MANUFACTURE | |
Revised: 01/2012 Contract Pharmacal Corp