ACETA-GESIC- acetaminophen and diphenhydramine hydrochloride tablet, coated
Rugby Laboratories
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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Do not use
Ask a doctor or pharmacist before use if you are
Stop use and ask a doctor if
pain persists for more than 10 days; fever persists for more than 3 days (unless directed by a doctor); condition worsens or new symptoms appear; redness or swelling is present. These could be signs of a serious condition.
If pregnant or nursing, as with any drug, seek the advise of a heath professional before using this product.
Directions
adults and children 12 years and over: take 1 to 2 tablets every six hours while symptoms last. Maximum daily dose is 9 tablets in 24 hours unless directed by a doctor.
children under 12 years: Do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and could cause serious health problems.
Other information
colloidal silicon dioxide, crospovidone, fd&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, pregelatinized starch, stearic acid
Uses: temporarily relieves minor aches and pains due to:
headache, backache, muscular aches, arthritis pain, colds, flu, fever, toothache, premenstrual cramps.
Warnings:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if: adult or child 12 years and older takes more than 12 tablets in 24 hours, which is the maximum daily amount; taking with other drugs containing acetaminophen; adult has 3 or more alcoholic drinks every day while using this product.
ACETA-GESIC
acetaminophen and diphenhydramine hydrochloride tablet, coated |
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Labeler - Rugby Laboratories (191427277) |
Registrant - Time Cap Labs, Inc. (037052099) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Time-Cap Labs, Inc | 037052099 | manufacture(0536-1003) |