Greenfield - Pain Relief Pm - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg) Diphenhydramine (25 mg)

Inactive Ingredients

Croscarmellose Sodium Fd&c Blue No. 1 Aluminum Lake Hypromellose, Unspecified Microcrystalline Cellulose Polyethylene Glycol, Unspecified Povidone Silicon Dioxide Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: AZ267 Shape: oval Color: blue Size: 16 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-11-23

Medication Information

Purpose

Pain reliever

Nighttime sleep aid

Description

Acetaminophen 500 mg Diphenhydramine HCl 25 mg

Use(s)

temporarily relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Warnings

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

more than 4000 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.

Directions

do not take more than directed (see overdose warning0
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

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

Other Information

store between 20-25 °C (68-77° F)
do not use if imprinted safety seal under cap is broken or missing
retain carton for full product information

Active Ingredient(s)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Inactive Ingredients

croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene

glycol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide

Pregnancy/breastfeeding

If pregnant or breastfeeding, ask a health professional before use.

Principal Display Panel

Pain Relief

When Using This Product

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

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

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.

You may report side effects to 1-888-952-0050

Keep Out of Reach of Children

Overdose warning: In case of overdose, get medical help or contact a Poison

Control Center right away. Quick medical attention is critical for adults as well as for children

even if you do not notice any signs or symptoms.

Ask A Doctor Or Pharmacist Before Use If

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Structured Label Content

Use(s)

temporarily relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Purpose

Pain reliever

Nighttime sleep aid

Warnings

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

more than 4000 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.

Directions

do not take more than directed (see overdose warning0
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

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

Other Information (Other information)

store between 20-25 °C (68-77° F)
do not use if imprinted safety seal under cap is broken or missing
retain carton for full product information

Active Ingredient(s) (Active ingredient(s))

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene

glycol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide

Pregnancy/breastfeeding (Pregnancy/Breastfeeding)

If pregnant or breastfeeding, ask a health professional before use.

Principal Display Panel

Pain Relief

When Using This Product (When using this product)

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

Ask A Doctor Before Use If (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

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 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.

You may report side effects to 1-888-952-0050

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. Quick medical attention is critical for adults as well as for children

even if you do not notice any signs or symptoms.

Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Use(s)": "temporarily relief of occasional headaches and minor aches and pains with accompanying sleeplessness", "Purpose": "Pain reliever Nighttime sleep aid", "Warnings": "Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4000 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.", "Directions": "do not take more than directed (see overdose warning0 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", "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", "Other information": "store between 20-25 °C (68-77° F) do not use if imprinted safety seal under cap is broken or missing retain carton for full product information ", "Active ingredient(s)": "Acetaminophen 500 mg Diphenhydramine HCl 25 mg", "Inactive ingredients": "croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide", "Pregnancy/Breastfeeding": "If pregnant or breastfeeding, ask a health professional before use.", "Principal Display Panel": "Pain Relief Pain Relief", "When using this product": "drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery", "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", "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. You may report side effects to 1-888-952-0050", "Keep out of reach of children": "Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "Ask a doctor or pharmacist before use if": "taking the blood thinning drug warfarin taking sedatives or tranquilizers"}

Greenfield - Pain Relief Pm