OTC Medication Information: ACETA-GESIC

ACETA-GESIC- acetaminophen and diphenhydramine hydrochloride tablet, coated
REMEDYREPACK INC.

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.

DRUG: ACETA-GESIC

GENERIC: ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE

DOSAGE: TABLET, COATED

ADMINSTRATION: ORAL

NDC: 61786-002-02

COLOR: orange

SHAPE: ROUND

SCORE: No score

SIZE: 11 mm

IMPRINT: TCL106

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • ACETAMINOPHEN 325mg in 1
  • DIPHENHYDRAMINE HYDROCHLORIDE 12.5mg in 1

INACTIVE INGREDIENT(S):

  • CELLULOSE, MICROCRYSTALLINE
  • MINERAL OIL
  • COLLOIDAL SILICON DIOXIDE
  • POVIDONE
  • STARCH, PREGELATINIZED CORN
  • CROSPOVIDONE
  • FD&C YELLOW NO. 6
  • MAGNESIUM STEARATE
  • HYPROMELLOSES
  • STEARIC ACID
Remedy_Label
(click image for full-size original)
ACETA-GESIC
acetaminophen and diphenhydramine hydrochloride tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61786-002(NDC:0536-1003)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE
FD&C YELLOW NO. 6
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
MINERAL OIL
POVIDONE
STARCH, PREGELATINIZED CORN
STEARIC ACID
Product Characteristics
Color orange Score no score
Shape ROUND Size 11mm
Flavor Imprint Code TCL106
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61786-002-02 30 TABLET, COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 08/08/2014
Labeler — REMEDYREPACK INC. (829572556)

Revised: 09/2016 REMEDYREPACK INC.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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