FDA Label for Pain Relief Pm Extra Strength

Other

Drug Facts

Otc - Purpose

Uses

temporary relief of occasional headaches and 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
• 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
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

Otc - Do Not Use

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 have ever had an allergic reaction to this product or any of its ingredients

Otc - Ask Doctor

Ask a doctor before use if you have

• liver disease
• a breathing problem such as emphysema or chronic bronchitis
• trouble urinating due to an enlarged prostate gland
• glaucoma

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

Otc - When Using

When using this product

• drowsiness will occur
• avoid alcoholic drinks
• do not drive a motor vehicle or operate machinery

Otc - Stop Use

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.
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur

These could be signs of a serious condition

Otc - Pregnancy Or Breast Feeding

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

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick 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 gelcaps at bedtime do not take more than 2 gelcaps of this product in 24 hours
children under 12 years	do not use

Other Information

• store between 20-25°C (68-77�F)
• retain carton for complete product information

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C red #28, D&C yellow #10, edible ink, FD&C blue #1, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, gelatin, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, titanium dioxide, triacetin

Questions Or Comments?

1-844-705-4384

Principal Display Panel

GoodSense(R)
NDC 50804-825-02
Extra Strength
Pain Relief PM
Pain Reliever/Nighttime Sleep-Aid
Acetaminophen

Diphenhyramine HCl
For Adults
Gelcaps
Rapid Release
20 GELCAPS
Compare to active ingredients of Tylenol(R) PM Rapid Release Gels
100% SATISFACTION GUARANTEED

image description - F117101GDS R0