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Acetaminophen and Diphenhydramine HCl

Medically reviewed on December 11, 2017

Dosage form: tablet
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 12.5mg, ACETAMINOPHEN 325mg
Labeler: Rugby Laboratories Inc.
NDC Code: 0536-3605

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.

Acetagesic

Active Ingredient

Acetaminophen 325 mg and Diphenhydramine HCl 12.5 mg

Purposes

Pain Reliever/Fever Reducer
Antihistamine

Uses

Temporarily reduces fever and relieves minor aches and pain caused by

  • common cold
  • headache
  • toothache
  • muscular aches
  • backache
  • arthritis
  • flu
  • premenstrual and menstrual cramps

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

  • adult or child 12 years and older takes more than 8 tablets in less than 24 hours which is the maximum daily amount
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks everyday 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.
  • with any other drug containing diphenhydramine, even one used on skin

    Ask a doctor before use if the user has

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

    Ask a doctor or pharmacist before use if the user is.

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

    When using this product

  • you may get very drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

    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
  • redness or swelling is present
  • any new symptoms appear

    If pregnant or breast feeding, ask a health professional before use.

    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). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions
  • adults and children 12 years & over: take 2 tablets every 4 hours, but not more than 8 tablets in 24 hours
  • children under 12 years: do not use

Other Information

Store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, FD&C yellow #6 (al-lake), hypromellose, microcrystalline cellulose, mineral oil, polyethylene glycol, povidone, pregelatinized starch, purified water, stearic acid, titanium dioxide.

QUESTIONS

Call 1-800-645-2158, 9 am – 5 pm ET, Monday – Friday.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

100 Tablets

NDC 0536-3605-01

Rugby

Acetaminophen 325 mg / Diphenhydramine HCl 12.5 mg

Pain Reliever, Fever Reducer, Antihistamine

ACETAMINOPHEN AND DIPHENHYDRAMINE HCL 
acetagesic tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-3605
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
CELLULOSE, MICROCRYSTALLINE 
MINERAL OIL 
POLYETHYLENE GLYCOL 450 
POVIDONE 
STARCH, CORN 
WATER 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorORANGE (peach) Scoreno score
ShapeROUNDSize10mm
FlavorImprint CodeAP;126
Contains    
Packaging
#Item CodePackage Description
1NDC:0536-3605-01100 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34306/12/2012
Labeler - Rugby Laboratories Inc. (191427277)
Registrant - Advance Pharmaceutical Inc. (078301063)
Establishment
NameAddressID/FEIOperations
Advance Pharmaceutical Inc.078301063MANUFACTURE(0536-3605)

 
Rugby Laboratories Inc.

← See all Acetaminophen and Diphenhydramine HCl brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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