Cvs Nighttime Liquid
FDA Label NDC 69842-448

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 for the product Cvs Nighttime (NDC 69842-448). 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 ingredients (in each 30 ml), purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredients (In Each 30 Ml)

Acetaminophen 1000 mg

Diphenhydramine HCl 50 mg

Purpose

Pain reliever

Nighttime sleep-aid

Uses

  • ▪for the temporary relief of occasional minor aches and pains with accompanying sleeplessness.

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

  • ▪adult takes more than 4 doses (30 mL each) in 24 hrs., which is the maximum daily amount for this product
  • ▪taken with other drugs containing acetaminophen
  • ▪3 or more alcoholic drinks every day while using this product

    • Allergy Alert: Acetaminophen may cause severe skin reactions.

    Symptoms may include:

    • ▪skin reddening
    • ▪blisters
    • ▪rash

      • If a skin reaction occurs, stop use and seek medical help right away

Otc - Do Not Use

Do not use

  • ▪with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • ▪for children under 12 years of age
  • ▪with any other product containing diphenhydramine, even one used on skin.

Otc - Ask Doctor

Ask a doctor before use if you have

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

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

Otc - When Using

When using this product

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

Otc - Stop Use

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • Sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

    • These could be signs of a serious condition.

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. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • ▪take only one dose (30 mL) per day (24 hours)
  • ▪Only use dose cup provided

    • adults & children 12 yrs & over

    30 mL at bedtime

    children under 12 yrs

    do not use

Other Information

  • ▪each 30 mL contains: sodium 10 mg
  • ▪store at room temperature
  • ▪very low sodium

Inactive Ingredients

citric acid, flavors, FD&C Blue No. 1, FD&C Red No. 40, glycerin, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose.

Questions Or Comments?

1-866-467-2748

Principal Display Panel - 354 Ml Bottle

Compare to the active ingredient in Vicks® ZzzQuil™ Night Pain Sleep-Aid*

NDC# 69842-448-12


Nighttime Sleep-Aid

Pain Reliever

Diphenhydramine HCl

Acetaminophen

  • Fall Asleep Fast
  • Max Strength Pain Reliever
  • Non-Habit Forming

    • Berry Flavor

    Naturally and Artificially Flavored

    No Added Alcohol

    12 FL. OZ. (354 ml)

    *This product is not manufactured or distributed by Procter & Gamble, the distributor of Vicks® ZzzQuil™ Nigh Pain Sleep-Aid.

    Distributed by:

    Cvs Nighttime Sleep Aid Berry Flavor (975)

    Cvs Nighttime Sleep Aid Berry Flavor (975)

* Please review the disclaimer below.