Meijer Nighttime Sleep-aid Solution
FDA Label NDC 41250-738

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Meijer Distribution Inc for the product Meijer Nighttime Sleep-aid (NDC 41250-738). 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 drug facts, purpose, uses, warnings, ask a doctor before use if you have, keep out of reach of children., directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Drug Facts

→ Purpose

→ Uses

→ Warnings

→ Ask A Doctor Before Use If You Have

→ Keep Out Of Reach Of Children.

→ Directions

→ Inactive Ingredients

→ Questions Or Comments?

→ Package Label-principal Display Panel 12 Fl Oz (354 Ml Bottle)

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

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.

When using this product

▪avoid alcoholic beverages

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 breast-feeding, ask a health professional before use.

Keep Out Of Reach Of Children.

Overdose warning: 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)
▪measure with dosing cup provide

adults & children 12 yrs & over	One Dose = 30 mL 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 requirement for light-resistant packaging.

Inactive Ingredients

anhydrous citric acid, FD&C Blue #1, FD&C Red #40, glycerin, natural and artificial flavor, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.