DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride liquid 
Westminster Pharmaceuticals, LLC

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.

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Diphenhydramine HCl

Drug Facts

Active ingredients (in each mL)

Diphenhydramine HCl 6.25 mg

Purpose

Antihistamine/Cough Suppressant

Uses

  • temporarily relieves:
    • runny nose
    • sneezing
    • itching of nose and throat
    • itchy, watery eyes due to hay fever or other upper respiratory allergies or allergic rhinitis
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • the intensity of coughing

Warnings

  • May cause excitability, especially in children
  • Marked drowsiness may occur
  • Sedatives and tranquilizers may increase drowsiness

Do Not Use

  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • cough accompanied by too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

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

When using this product

  • do not use more than directed
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • nervousness, dizziness or sleeplessness occurs
  • symptoms do not improve within 7 days or are accompanied by a fever, rash or persistent headache

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.

Directions

  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours or as directed by a doctor
  • do not give more than directed or exceed the recommended daily dosage
Adults and children 12 years of age and over4 mL
Children 6 to 12 years of age2 mL
Children under 6 years of ageAsk a doctor
  • use only with enclosed dropper
  • do not use enclosed dropper for any other drug product

Other Information

  • store at controlled room temperature 15°-30°C (59°-86°F)
  • Tamper Evident: Do not use if seal is broken or missing.

Inactive Ingredients

Citric acid, FD&C Blue #1, glycerin, methylparaben, monoammonium glycyrrhizinate, potassium citrate, potassium sorbate, propylene glycol, propylparaben, purified water, sucralose

Questions?

Call 1-844-221-7294

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

NDC 69367-187-30

Diphenhydramine HCl

Each 1 mL contains:
Diphenhydramine HCl
6.25 mg

Antihistamine/Cough Suppressant

Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.

1 oz. (30 mL)

Westminster
Pharmaceuticals

Principal Display Panel - 30 mL Bottle Carton
DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69367-187
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE6.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69367-187-301 in 1 CARTON03/15/201812/31/2021
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/15/201812/31/2021
Labeler - Westminster Pharmaceuticals, LLC (079516651)

Revised: 3/2018
 
Westminster Pharmaceuticals, LLC