NOTTS - Pain Relief PM (notts - pain relief pm (acetaminophen, diphenhydramine hydrochloride) tablet) Dailymed

Otc - Active Ingredient Section

OTC - PURPOSE SECTION

Active ingredients (in each caplet)	Purpose
Acetaminophen 500 mg	Pain Reliever
Diphenhydramine HCl 25 mg	Nighttime Sleep Aid

Uses

Temporary relief of occasional headaches, minor aches and pains with accompanying sleeplessness

Warnings

Liver Warning

This product contains acetaminophen. Severe liver damage may occur if you take

• more than 4,000 mg of acetaminophen in 24 hours, which is the maximum daily amount.
• 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
• rash
• bulers

If a skin reaction occurs, stop use and seek medical attention immediately.

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.
• with any other product containing diphenhydramine, even one used on skin
• in children under 12 years of age
• if you are allergic to any other ingredient in this product.

Ask a doctor before use if you have

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

When using this product

avoid alcoholic drinks

Ask a doctor or pharmacist before use if you are taking

• the blood thinning drug warfarin
• sedatives or tranquilizers

Stop use and ask a doctor if

• sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness.
• pain lasts more than 10 days
• pain gets worse
• new symptoms occur
• redness or swelling is present.

These could be signs of a serious condition.

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

Do not take more the recommended dosage. In case of overdose, get medical help or contact a Poison Control Center. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• Do not take more than directed (see overdose warning)

adults and children 12 years and over	take 2 caplets at bedtime if needed, or as directed by a doctor. do not take more than 2 caplets in 24 hours
children under 12 years	do not use

Other Information

• Store between 20-25°C (68-77°F)
• Tamper-evident: Do not use if carton is open or if the foil inner seal is broken or missing.

Inactive Ingredients

Croscarmellose Sodium, Corn Starch, FD&C Blue No. 1 Aluminium Lake, FD&C Blue No. 2 Aluminium Lake, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Povidone K30, Silicon Dioxide, Sodium Starch Glycolate, Talc, Titanium Dioxide.

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., owner of the registered trademark Tylenol ® Extra Strength PM.

Distributed by:

VIVUNT PHARMA LLC

8950 SW 74th Court, Suite 1901

Miami, Florida FL 33156-3178

Made in India

Principal Display Panel - 24 Caplets

NOTTSâ„¢

Pain Relief PM

Acetaminophen,

Diphenhydramine HCl

​500 mg/ 25 mg each caplet

Pain Reliever Nighttime Sleep Aid Non-habit Forming

Compare to Tylenol® Extra Strength PM active ingredients*

NDC 82706-009-01

24 CAPLETS

Principal Display Panel - 50 Caplets

NOTTSâ„¢

Pain Relief PM

Acetaminophen,

Diphenhydramine HCl

500 mg/ 25 mg each caplet

​

• Pain Reliever
• Nighttime Sleep Aid
• Non-habit Forming

Compare to Tylenol® Extra Strength PM active ingredients*

NDC 82706-009-02

50 CAPLETS