Cvs health nighttime sleep-aid liquid

Spl unclassified section

Drug Facts

Active ingredient (in each 30 ml)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Uses

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

Warnings

Do not use

  • 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

Ask a doctor before use if you have

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

Otc - ask doctor/pharmacist section

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers or any other sleep- aid.

When using this product

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

Otc - stop use section

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

Otc - pregnancy or breast feeding section

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

Otc - keep out of reach of children section

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.1-800-222-1222

Directions

  • take only one dose per day (24 hours) see Overdose warning
  • Measure with dosing cup provided

adults & children 12 yrs & over

One Dose = 30 mL (2 tablespoons) at bed time if needed or as directed by a doctor

Children under 12 yrs

do not use

Other information

  • each 30 mL dose contains : sodium 23 mg
  • store at room temperature
  • protect from light. Does not meet USP <671>

Inactive ingredients

anhydrous citric acid, FD&C blue 1, FD&C red 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

Ingredients and appearance - Product information

Cvs health nighttime sleep-aid liquid- Diphenhydramine hydrochloride

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 59779-893
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Diphenhydramine hydrochloride ( UNII: TC2D6JAD40)( Diphenhydramine - UNII: 8GTS82S83M ) 50 mgin 30 mL

Inactive Ingredients

Ingredient Name Code
Anhydrous citric acid ( UNII: XF417D3PSL)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Fd&c red no. 40 ( UNII: WZB9127XOA)
Glycerin ( UNII: PDC6A3C0OX)
Potassium citrate ( UNII: EE90ONI6FF)
Water ( UNII: 059QF0KO0R)
Sodium benzoate ( UNII: OJ245FE5EU)
Sorbitol ( UNII: 506T60A25R)
Sucralose ( UNII: 96K6UQ3ZD4)
Xanthan gum ( UNII: TTV12P4NEE)

Product Characteristics

Color PURPLE Flavor BERRY

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part338 USA

Labeler - CVS Pharmacy,Inc.( 062312574)

Principal display panel

VALUE TWIN PACK

CVS Health

Compare to the active ingredient in ZzzQuil™ Nighttime Sleep-Aid*

NDC 59779-893-24

SEE NEW WARNINGS

Alcohol Free

Nighttime

Sleep-Aid

DIPHENHYDRAMINE HCL

  • Non-habit forming
  • Not for treating cold or flu

Berry Flavor

Naturally & artificially flavored

2 BOTTLES

12 FL OZ (354 mL) EACH;

24 FL OZ (708 mL) TOTAL

Failure to follow these warnings could result in serious consequences.

TAMPER EVIDENT: DO NOT USE IF PRINTED SHRINK BAND IS MISSING OR BROKEN

*This product is not manufactured or distributed by Proctor & Gamble, the distributor of ZzzQuil™ Nighttime Sleep- Aid.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2017 CVS/pharmacy

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