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ACETA-GESIC by Rugby Laboratories

Medically reviewed on July 2, 2018

Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 325mg, DIPHENHYDRAMINE HYDROCHLORIDE 12.5mg
Labeler: Rugby Laboratories
NDC Code: 0536-1003

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.


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.

with any other product containing diphenhydramine, even one used on skin

Ask doctor or pharmacist before use if you are:

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

Ask a doctor before use if you have

  •  liver disease
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

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); conditions worsen 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 advice of a health professional before using this product.

Keep this and all drugs out of the reach of children

Directions:

  • adults and children 12 years and over: take 1 or 2 tablets every six hours while symptoms last. Maximum daily dose is 8 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

Uses: temporarily relieves minor aches and pains due to: headache, backache, muscular aches, arthritis pain, colds, flu, fever, toothache, premenstrual cramps.

colloidal silicon dioxide, crospovidone, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, pregelatinized starch, stearic acid

Each tablet contains:

Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

Pain Reliever-Fever Reducer-Antihistamine

Warnings:

Liver warning: This product contains acetaminophen. Sever liver damage may occur if: adult or child 12 years and older takes more than 8 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
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1003
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg
Inactive Ingredients
Ingredient NameStrength
COLLOIDAL SILICON DIOXIDE 
CROSPOVIDONE 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
MINERAL OIL 
POVIDONE 
STARCH, PREGELATINIZED CORN 
STEARIC ACID 
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize11mm
FlavorImprint CodeTCL106
Contains    
Packaging
#Item CodePackage Description
1NDC:0536-1003-01100 TABLET, COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/30/2014
Labeler - Rugby Laboratories (079246066)
Registrant - TIME CAP LABS, INC. (037052099)
Establishment
NameAddressID/FEIOperations
TIME-CAP LABS, INC037052099manufacture(0536-1003)

 
Rugby Laboratories

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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