Premier Value Sleep-aid
FDA Label NDC 68016-302

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Consortium Llc for the product Premier Value Sleep-aid (NDC 68016-302). 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 active ingredient(s), purpose, use(s), warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient(S)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep- aid

Use(S)

  • helps to reduce difficulty falling asleep

Warnings

Do not give to children under 12 years of age.

Do Not Use

  • With other products containing diphenhydramine, even one used on skin.

Ask A Doctor Before Use If

  • emphysema
  • chronic bronchitis
  • glaucoma
  • difficulty in urination due to an enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use If

Sedatives or tranquilizers

When Using This Product

Avoid alcoholic beverages

Stop Use And Ask Doctor If

  •  Sleeplessness persists for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

Pregnancy/Breastfeeding

Ask a health professional before use.

Keep Out Of Reach Of Children

In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

  • adults and children 12 years of age and over: take 1 softgel at bedtime if needed or as directed by a doctor

Storage

  • Store at controlled room temperature 15°-30°C (59°-86°F)
  • do not use if imprinted safety seal under cap is broken or missing
  • *This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Maximum Strength Unisom SleepGels®

Inactive Ingredients

Gelatin, Sorbitol, Sorbitan, FD&C Blue No. 1, Water, Polyethylene Glycol 400, Povidone K-30

Principal Display Panel

Carton Label PDP

NDC # 68016-302-32

Sleep-Aid
DIPHENHYDRAMINE HCL 50 mg

GET TO SLEEP FAST
SLEEP SOUNDLY
WAKE REFRESHED

32 Softgels


Diphen-carton-lab (Fig 4)

Diphen-carton-lab (Fig 4)







Bottle Label PDP

NDC # 68016-302-32

Sleep-Aid
DIPHENHYDRAMINE HCL 50 mg

GET TO SLEEP FAST
SLEEP SOUNDLY
WAKE REFRESHED

32 Softgels


Diphen-bott-label (Fig 2)

Diphen-bott-label (Fig 2)



* Please review the disclaimer below.