Extra Strength Pain Relief Pm

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg) Diphenhydramine (25 mg)

Inactive Ingredients

Silicon Dioxide Croscarmellose Sodium D&c Yellow No. 10 Fd&c Blue No. 1 Hypromelloses Cellulose, Microcrystalline Mineral Oil Polyethylene Glycols Polyvinyl Alcohol Povidone Sodium Starch Glycolate Type A Corn Stearic Acid Talc Titanium Dioxide Triacetin Ferric Oxide Yellow

Identifiers & Packaging

Pill Appearance

Imprint: V15AV;S525;CPC752 Shape: capsule Color: blue Size: 7 mm Score: 1

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2012-05-14

Medication Information

Purpose

Pain reliever

Nighttime sleep aid

Description

Acetaminophen 500 mg Diphenhydramine HCl 25 mg

Uses

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

Section 50565-1

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 (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.

Section 53414-9

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

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

Directions

do not take more than directed
adults and children 12 years and over: take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours.
children under 12 years: 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.

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

Product Labeling

**Compare to the active

ingredients in Tylenol® PM®

EXTRA STRENGTH

Pain Relief PM

Acetaminophen 500 mg, Diphenhydramine HCl 25 mg

Pain reliever /

Nighttime Sleep-Aid

24 CAPLETS

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

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
**This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered

trademark Tylenol® PM

Inactive Ingredients

colloidal silicon dioxide*, croscarmellose sodium*, Dand C Yellow No. 10 Aluminum Lake*, FDandC Blue No.1 Aluminum Lake, FDandC Blue No. 2 Aluminum Lake, hypromellose, magnesium silicate*, magnesium stearate*, microcrystalline cellulose, mineral oil*, polyethylene glycol,

polyvinyl alcohol*, povidone, pregelatinized starch, silica*, sodium starch glycolate*, stearic acid, talc*, titanium dioxide, triacetin*, and yellow iron oxide*

*contains one or more of these ingredients

When Using This Product

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

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
redness or swelling is present
new symptoms occur

Active Ingredients (in Each Caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

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 the blood thinning drug warfarin
taking sedatives or tranquilizers

Structured Label Content

Uses

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

Section 50565-1 (50565-1)

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 (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.

Section 53414-9 (53414-9)

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

Purpose

Pain reliever

Nighttime sleep aid

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

Directions

do not take more than directed
adults and children 12 years and over: take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours.
children under 12 years: 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.

Do Not Use (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
if you have ever had an allergic reaction to this product or any of its ingredients

Product Labeling

**Compare to the active

ingredients in Tylenol® PM®

EXTRA STRENGTH

Pain Relief PM

Acetaminophen 500 mg, Diphenhydramine HCl 25 mg

Pain reliever /

Nighttime Sleep-Aid

24 CAPLETS

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

Other Information (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
**This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered

trademark Tylenol® PM

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide*, croscarmellose sodium*, Dand C Yellow No. 10 Aluminum Lake*, FDandC Blue No.1 Aluminum Lake, FDandC Blue No. 2 Aluminum Lake, hypromellose, magnesium silicate*, magnesium stearate*, microcrystalline cellulose, mineral oil*, polyethylene glycol,

polyvinyl alcohol*, povidone, pregelatinized starch, silica*, sodium starch glycolate*, stearic acid, talc*, titanium dioxide, triacetin*, and yellow iron oxide*

*contains one or more of these ingredients

When Using This Product (When using this product)

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

Stop Use and Ask A Doctor If (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
redness or swelling is present
new symptoms occur

Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "Temporary relief of occasional headaches, minor aches, and pains accompanying sleeplessness.", "50565-1": "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 (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.", "53414-9": "If pregnant or breast-feeding , ask a health care professional before use.", "Purpose": "Pain reliever Nighttime sleep aid", "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", "Directions": "do not take more than directed adults and children 12 years and over: take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours. children under 12 years: 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.", "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 if you have ever had an allergic reaction to this product or any of its ingredients", "Product Labeling": "**Compare to the active ingredients in Tylenol® PM® EXTRA STRENGTH Pain Relief PM Acetaminophen 500 mg, Diphenhydramine HCl 25 mg Pain reliever / Nighttime Sleep-Aid 24 CAPLETS Do not use if imprinted safety seal under cap is broken or missing", "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 **This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® PM", "Inactive ingredients": "colloidal silicon dioxide*, croscarmellose sodium*, Dand C Yellow No. 10 Aluminum Lake*, FDandC Blue No.1 Aluminum Lake, FDandC Blue No. 2 Aluminum Lake, hypromellose, magnesium silicate*, magnesium stearate*, microcrystalline cellulose, mineral oil*, polyethylene glycol, polyvinyl alcohol*, povidone, pregelatinized starch, silica*, sodium starch glycolate*, stearic acid, talc*, titanium dioxide, triacetin*, and yellow iron oxide* *contains one or more of these ingredients", "When using this product": "drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery", "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 redness or swelling is present new symptoms occur", "Active ingredients (in each caplet)": "Acetaminophen 500 mg Diphenhydramine HCl 25 mg", "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 the blood thinning drug warfarin taking sedatives or tranquilizers"}