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Acetaminophen and Diphenhydramine HCl

Medically reviewed on December 11, 2017

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Rugby Laboratories Inc.
NDC Code: 0536-3479

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.

Acetaminophen and Diphenhydramine HCl Captabs

Active Ingrdient

(in each captab)

PURPOSE

Pain Reliever/Sleep Aid

Uses

Temporarily relieves occasional headaches and minor aches and pains with accompanying sleeplessness.

Warnings

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

  • more than 8 captabs in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 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
  • in children under 12 years of age

    Ask a doctor before use if you have

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

    Ask a doctor or pharmacist before use if you are.

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

    When using this product

  • marked drowsiness will occur
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • do not drive motor vehicle or operate machinery

    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
  • sleeplessness lasts more than 2 weeks. Insomnia may be a sign of serious underlying medical illness.

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

    Keep out of children.

    In case of overdose, get medical help or contact a Poison Control Center right away. 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 or over:

  • take 2 captabs at bedtine if needed
  • do not take more than directed

childrens under 12 years do not use

Other Information

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

Inactive Ingredients

Croscarmellose sodium, FD&C blue #1, hypromellose, microcrystalline cellulose, polyethylene glycol 400, povidone, pregelatinized corn starch, silicon dioxide, stearic acid, titanium dioxide.

QUESTIONS

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50 Captabs Bottle Carton

NDC 0536-3479-06

Rugby

ACETAMINOPHEN 500 mg / Diphenhydramine HCl 25 mg

Pain Reliever / Sleep Aid

50 Captabs

ACETAMINOPHEN AND DIPHENHYDRAMINE HCL 
acetaminophen and diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-3479
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
FD&C BLUE NO. 1 
HYPROMELLOSES 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 400 
POVIDONE 
STARCH, CORN 
SILICON DIOXIDE 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorBLUE (light blue) Scoreno score
ShapeCAPSULESize17mm
FlavorImprint CodeAP;133
Contains    
Packaging
#Item CodePackage Description
1NDC:0536-3479-0650 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34310/06/2010
Labeler - Rugby Laboratories Inc. (191427277)
Registrant - Advance Pharmaceutical Inc. (078301063)
Establishment
NameAddressID/FEIOperations
Advance Pharmaceutical Inc.078301063MANUFACTURE(0536-3479)

 
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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