VALUMEDS NIGHTTIME SLEEP-AID

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each softgel)

Diphenhydramine HCl 25 mg

Purpose

nighttime sleep-aid

Uses

• for the relief of occasional sleeplessness
• reduces time to fall asleep if you have difficulty falling asleep

WARNINGS SECTION

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 asthma, emphysema, or chronic bronchitis
• glaucoma
• difficulty in urination due to enlargement of the prostate gland
• heart disease

OTC - ASK DOCTOR/PHARMACIST SECTION

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

Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Other information

• store at 20-25°C (68-77°F)
• avoid excessive heat above 40°C (104°F) and high humidity
• Protect from light

Inactive ingredients

FD&C Blue#1, FD&C Red#40, gelatin, glycerin, polyethylene glycol-400, propylene glycol, sorbitol sorbitan, titanium dioxide

SPL UNCLASSIFIED SECTION

Distributed By:

Spirit Pharmaceuticals, LLC

Ronkonkoma, NY 11779