Pain Relief PM

Avema Pharma Solutions

Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients (in each caplet)
• Purpose
• Pain Relief PM Uses
• Warnings
  • Do not use
  • Ask a doctor before use if you have
  • Ask a doctor or pharmacist before use if you are
  • When using this product
  • Stop use and ask a doctor if
• Directions
• Pain Relief PM Other information
• Inactive ingredients
• Package/Label Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredients (in each caplet)

Acetaminophen 500 mg*

Diphenhydramine HCl 25 mg**

Purpose

*Pain reliever

**Nighttime sleep aid

Pain Relief PM Uses

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

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur with this product if you take:

• more than 2 caplets 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

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Do not use

• with other products containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• in children under 12 years of age
• with other products containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

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

When using this product

avoid alcoholic beverages

do not drive a motor vehicle or operate machinery. This product will cause drowsiness.

Stop use and ask a doctor if

• sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
• pain gets worse or lasts for more than 10 days
• fever gets worse or lasts for more than 3 days
• new symptoms occur
• redness or swelling is present

If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children.

Directions

• do not exceed recommended dose
• adults and children 12 years of age and over: take 2 caplets at bedtime. Do not take more than 2 caplets in 24 hours.
• children under 12 years of age: do not use this product in children under 12 years of age. This will provide more than the recommended dose (overdose) and may cause liver damage.

Pain Relief PM Other information

• store at room temperature 15°-30°C (59°-86°F), avoid high humidity and excessive heat
• do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

FD&C Blue #1 Aluminum Lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG), polyvinyl alcohol, polyvinylpyrrolidone, sodium carboxymethyl starch, starch, stearic acid, talc, titanium dioxide.

Package/Label Principal Display Panel

NDC 63548-2341-*1

SEE NEW WARNINGS INFORMATION

EXTRA STRENGTH

Pain Relief PM

Pain reliever

Nighttime Sleep-Aid

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

24 CAPLETS

Do not use if imprinted safety seal under cap is broken or missing