DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride capsule, liquid filled capsule, liquid filled 
AMZ789 LLC

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Diphenhydramine HCl 25 mg

Diphenhydramine HCl 25 mg

Nighttime sleep-aid

for the relief of occasional sleeplessness
reduces time to fall asleep if you have difficulty falling asleep

Warnings

  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
  • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
  • do not use with NyQuil

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

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep aid

  • avoid alcoholic beverages and other drugs that cause drowsiness
  • drowsiness will occur
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

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

Keep out of reach of children. Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.

take only one dose per day (24 hours) - see Overdose warning

adults & Children 12 yrs & over

One dose = TWO 25mg softgels (50mg)

at bedtime if needed or as directed by a doctor

FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special and white edible ink

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DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule, liquid filled capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73629-007
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
GELATIN (UNII: 2G86QN327L)  
SORBITOL (UNII: 506T60A25R)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorpurpleScorescore with uneven pieces
ShapeCAPSULE (Oblong) Size15mm
FlavorImprint Code PC11
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73629-007-22220 in 1 BOTTLE; Type 0: Not a Combination Product10/18/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01010/18/2023
Labeler - AMZ789 LLC (117410213)

Revised: 1/2024
Document Id: 12dd2419-b2e1-5466-e063-6394a90a4221
Set id: 12dd2419-b2e0-5466-e063-6394a90a4221
Version: 1
Effective Time: 20240101
 
AMZ789 LLC