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Diphenhist by Rugby Laboratories Inc.

Medically reviewed on December 16, 2017

Dosage form: liquid
Ingredients: Diphenhydramine Hydrochloride 12.5mg in 5mL
Labeler: Rugby Laboratories Inc.
NDC Code: 0536-0770

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.

Diphenhist®

Drug Facts

Active ingredient (in each 5 mL)

Diphenhydramine HCl USP 12.5 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

Warnings

Do not use
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • a sodium-restricted diet

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product
  • avoid alcoholic drinks
  • marked drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions
  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
  • use only with enclosed dose cup. Do not use with any other device
  • mL = milliliter
Adults and children 12 years of age and over10 mL-20 mL (25 mg to 50 mg)
Children 6 to 12 years of age5 mL- 10 mL (12.5 mg to 25 mg)
Children 2 to 5 years of ageDo not use unless directed by a doctor
Children under 2 years of ageDo not use

Other information
  • each 5 mL contains: sodium 7 mg
  • store at room temperature 20°-25°C (68°-77°F)

Inactive ingredients

artificial cherry flavor, citric acid, D&C red #33, FD&C red #40, glycerin, polysorbate 20, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution.

Questions or comments?

1-800-645-2158

Distributed By: Rugby Laboratories
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

Rugby®

NDC 0536-0770-97

ALCOHOL-FREE
ALLERGY MEDICATION

Diphenhist®

ORAL SOLUTION
(Diphenhydramine HCl, USP)

Antihistamine

For Temporary Relief
of Symptoms of Upper Respiratory
Allergies and Hay Fever

4 fl oz (118 mL)

DIPHENHIST 
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-0770
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diphenhydramine Hydrochloride (Diphenhydramine) Diphenhydramine Hydrochloride12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
D&C RED NO. 33 
FD&C RED NO. 40 
Glycerin 
Polysorbate 20 
Water 
Sodium Benzoate 
SODIUM CITRATE, UNSPECIFIED FORM 
Saccharin Sodium 
Sorbitol 
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0536-0770-97118 mL in 1 BOTTLE
2NDC:0536-0770-85473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34109/26/2009
Labeler - Rugby Laboratories Inc. (079246066)

 
Rugby Laboratories Inc.

See Also

Further information

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

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