TRANQUIL NIGHTTIME- diphenhydramine hydrochloride tablet 
Alva-Amco Pharmacal Companies, Inc.

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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Tranquil

Active ingredient (in each tablet)

Diphenhydramine hydrochloride, 25 mg

Purpose

Nighttime sleep aid

Uses

For relief of occasional sleeplessness. Helps to reduce difficulty falling asleep.

Warnings


Do not use

  • with any other product containing diphenhydramine, even one used on the skin
  • in children under 12 years of age

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers
  • taking any other medications.

When using this product

  • avoid alcoholic beverages
  • drowsiness may occur
  • do not drive a motor vehicle or operate machinery

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

If pregnant or breastfeeding, 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

  • Read all package directions and warnings before use.
  • Use only as directed.
  • Adults:  Take 2 tablets at bedtime if needed or as directed by a doctor.
  • For use by normally healthy adults only.
  • Persons under 18 years of age should use only as directed by a doctor.

Other information

  • Calcium content:  64 mg/tablet.
  • **Contents sealed:  Each Tranquil Nighttime Sleep Aid white colored tablet bears the identifying mark "ALVA" and is packaged in a bottle with a safety seal under the cap. Do not use if seal appears broken or if product contents do not match product description.
  • You may report serious side effects to the phone number provided under Questions? below.

Inactive ingredients

Crocarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose.

Questions?  1-800-792-2582

Tranquil Nighttime PDP

TRANQUIL  NIGHTTIME
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52389-610
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: 701EKV9RMN)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize10mm
FlavorImprint Code ALVA
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52389-610-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/30/201003/31/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33808/30/201003/31/2014
Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)

Revised: 11/2018
 
Alva-Amco Pharmacal Companies, Inc.