Nighttime Sleep Aid Solution
FDA Label NDC 0363-7300

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Company for the product Nighttime Sleep Aid (NDC 0363-7300). 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), 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

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

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

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When Using This Product

  • ▪avoid alcoholic beverages

Otc - Stop Use

Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a 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. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222

Directions

  • ▪take only one dose per day (24 hours)
  • ▪only use the dose cup provided

    • adults & children 12 yrs & over

    30 mL at bed time if needed or as directed by a doctor

    children under 12 yrs

    do not use

Inactive Ingredients

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

Questions Or Comments?

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