ALLERGY- diphenhydramine hcl tablet 
Mechanical Servants, 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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Allergy

Active ingredient

(in each caplet)

Diphenhydramine HCl (25 mg)

Antihistamine

Warnings

Do not use

Ask a doctor before use if you have

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

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
  • excitability may occur, especially in children
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

If pregnant or breast-feeding

ask a health professional before use

Keep out of the reach of children

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

Directions

adults and children 12 years and over         1 to 2 tablets

children 6 to under 12 years                       1 tablet

children under 6 years                               ask a doctor

Inactive ingredients

colloidal silicon dioxide, corn starch, D & C red # 27 Aluminum lake, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, stearic acid, talc, titanium dioxide

Questions or comments?

Call 1-844-428-2538

Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies

Temporarily relieves these symptoms due to common cold

ALLERGY

Diphenhydramine HCI 25mg | Antihistamine

Runny Nose Nasal Congestion

Sneezing Itchy Watery Eyes

COMPARE TO THE ACTIVE INGREDIENTS IN

BENADRYL® *

6 TABLETS

ALLERGY

ALLERGY 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-7007
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STARCH, CORN (UNII: O8232NY3SJ)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
Colorpink (Pink) Scoreno score
ShapeOVALSize11mm
FlavorImprint Code PH25
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:29485-7007-66 in 1 PACKAGE03/13/2019
12 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/13/2019
Labeler - Mechanical Servants, LLC (005530951)

Revised: 10/2021
Document Id: b450462a-e93f-559e-e053-2a95a90abd17
Set id: a1e4781a-6715-461a-9289-94da68129f4a
Version: 3
Effective Time: 20211006
 
Mechanical Servants, LLC