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Rugby Acetaminophen 500 mg and Diphenhydramine HCl 25 mg Pain Reliever/Sleep Aid

Medically reviewed on Jun 27, 2017

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: RUGBY LABORATORIES
NDC Code: 0536-1015

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.

Rugby Acetaminophen 500 mg & Diphenhydramine HCl 25 mg Captabs

Drug Facts

Active ingredients (in each Captab)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Purposes

Pain Reliever

Nighttime Sleep Aid

Uses

Temporary relief of 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 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

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.
  • in children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland
  • glaucoma

Ask a doctor or pharmacist before use if you are

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

When using this product

  • drowsiness will occur
  • avoid alcoholic drinks
  • do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if

  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition.

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

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

​Directions

  • Do not take more than directed (see overdose warning)

Adults and children 12 years and over: Take 2 captabs at bedtime. Do not take more than 2 captabs of this product in 24 hours

Children under 12 years: do not use

Other information

  • Store at room temperature

Inactive ingredients Croscarmellose sodium, crospovidone, FD&C blue #1, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, silica, sodium starch glycolate, stearic acid and titanium dioxide.

Questions or comments? Call 1-800-645-2158

Do not use if imprinted safety seal under cap is broken or missing

Distributed by: Rugby Laboratories

17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152

www.rugbylaboratories.com

COMPARE TO ACTIVE INGREDIENTS IN EXTRA STRENGTH Tylenol® PM*

Rugby®

NDC 0536-1015-06

See New Warnings Information & Directions

Acetaminophen 500 mg and Diphenhydramine HCl 25 mg

Pain Reliever / Sleep Aid

50 CAPTABS

* Rugby Laboratories is not affiliated with the owner of the registered trademark Tylenol®

RUGBY ACETAMINOPHEN 500 MG AND  DIPHENHYDRAMINE HCL 25 MG PAIN RELIEVER/SLEEP AID
acetaminophen,diphenhydramine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1015
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 
CROSPOVIDONE 
FD&C BLUE NO. 1 
HYDROXYPROPYL CELLULOSE (TYPE H) 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE 
STARCH, CORN 
PROPYLENE GLYCOL 
SILICON DIOXIDE 
SODIUM STARCH GLYCOLATE TYPE A CORN 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
Colorblue (Film Coated) Scoreno score
ShapeCAPSULE (Capsule Shaped Tablet) Size18mm
FlavorImprint CodeGP325
Contains    
Packaging
#Item CodePackage Description
1NDC:0536-1015-0650 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/26/2014
Labeler - RUGBY LABORATORIES (079246066)
Registrant - GEMINI PHARMACEUTICALS INC. (055942270)
Establishment
NameAddressID/FEIOperations
GEMINI PHARMACEUTICALS INC.055942270manufacture(0536-1015)

 
RUGBY LABORATORIES

Further information

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

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