FDA Label for Notts - Pain Relief Pm

Other

Drug Facts

Product of China

Distributed by:

VIVUNT PHARMA LLC

8950 SW 74th Court, Suite 1901

Miami, Florida Z.C. 33156-3175

Otc - Purpose

Uses

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

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
• blisters

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 of 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
• a sodium restricted diet
• kidney disease
• a magnesium restricted diet

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

Keep out of reach of children.

Overdose Warning

Do not take more the recommended. 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)
• Each caplet contains: sodium 9 mg and magnesium 75 mg
• Tamper-evident: Do not use if carton is open or if the foil inner seal is broken or missing.

Inactive Ingredients

Copovidone K25, Corn Starch, Croscarmellose Sodium, FD&C Blue No. 1, Hypromellose, Lactose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Sodium Starch Glycolate Type A Corn, Silicon Dioxide, Stearic Acid, Titanium Oxide.

Principal Display Panel - 24 Caplets

NOTTS™

Pain Relief PM

Acetaminophen/ Diphenhydramine HCl

​

Pain Reliever
Nighttime Sleep Aid
Non-habit Forming

Compare to Tylenol® Extra Strength PM active ingredients*

NDC 82706-009-01

500 mg/ 25 mg each caplet

24 CAPLETS

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

Principal Display Panel - 50 Caplets

NOTTS™

Pain Relief PM

Acetaminophen/ Diphenhydramine HCl

​

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


Compare to Tylenol® Extra Strength PM active ingredients*

NDC 82706-009-02

500 mg/ 25 mg each caplet

50 CAPLETS

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