Cvs Health Nighttime Sleep-aid Liquid
FDA Label NDC 59779-893

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy,inc. for the product Cvs Health Nighttime Sleep-aid (NDC 59779-893). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each 30 ml dose cup or 2 tablespoons), purpose, uses, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient (In Each 30 Ml Dose Cup Or 2 Tablespoons)

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

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

Ask a doctor or pharmacist before use if you are taking 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

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.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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
  • use dose cup or tablespoon

    • adults & children 12 yrs & over

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

Other Information

  • each 30 mL dose (2 tablespoons) contains: sodium 23 mg
  • store at room temperature
  • protect from light. Does not meet USP

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.

Principal Display Panel

CVS Health ™

Compare to the active ingredient in ZzzQuil® Nighttime Sleep-Aid

SEE NEW WARNINGS

Nighttime

Sleep-Aid

DIPHENHYDRAMINE HCL

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

    • Berry Flavor

    Naturally & artificially flavored

    12 FL OZ (354 mL)

    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®.

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    © 2015CVS/pharmacy

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    V-30486

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    Cvs Health Nighttime Sleep Aid Berry Flavor 12 Fl Oz (Image 01)

    Cvs Health Nighttime Sleep Aid Berry Flavor 12 Fl Oz (Image 01)

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