Goodys Pm - 63029-656

Goodys Pm - 63029-656
SPL v5
SPL
SPL Set ID db5d6c2b-688e-4e88-a42d-0fa2b0d8140b
Route
ORAL
Published
Effective Date 2024-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Diphenhydramine (38 mg)
Inactive Ingredients
Citric Acid Monohydrate Docusate Sodium Fumaric Acid Lactose Monohydrate Magnesium Stearate Potassium Chloride Silicon Dioxide Sodium Benzoate Trisodium Citrate Dihydrate Glycine

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-09-01

Description

Drug Facts

Purpose

Pain reliever Nighttime sleep-aid


Medication Information

Purpose

Pain reliever Nighttime sleep-aid

Description

Drug Facts

Uses

• temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Section 42229-5

Drug Facts

Purposes

Pain reliever

Nighttime sleep-aid

Warnings

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.

Directions

• do not take more than directed (see overdose warning)

adults and children 12 years of age and over: take 2 powders at bedtime, if needed, or as directed by a doctor. Drink a full glass of water with each dose, or may stir powder into a glass of water or other liquid.

do not give to children under 12 years of age

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.

• in children under 12 years of age

• with any other product containing diphenhydramine, even one used on skin

Other Information

• each powder contains: potassium 42 mg

• store below 25°C (77°F)

Overdose Warning:

Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredients

(in each powder)

Acetaminophen 500 mg

Diphenhydramine Citrate 38 mg

Inactive Ingredients

citric acid, docusate sodium, fumaric acid, glycine, lactose monohydrate, magnesium stearate, potassium chloride, silica gel, sodium benzoate, sodium citrate dihydrate

Questions Or Comments?

1-866-255-5197 

Principal Display Panel

Goody’s PM

Acetaminophen • Diphenhydramine Citrate

Pain Reliever/ Nighttime sleep-aid

FOR PAIN WITH SLEEPLESSNESS

16 Powder Packs

When Using This Product

• drowsiness will occur

• avoid alcoholic drinks

• be careful when driving a motor vehicle or operating 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 more than 10 days

• redness or swelling is present

• any new symptoms appear

These could be signs of a serious condition.

If Pregnant Or Breast Feeding

ask a health professional before use.

Ask A Doctor Before Use If You Have

• liver disease

• glaucoma

• a breathing problem such as emphysema or chronic bronchitis

• trouble urinating due to an enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are Taking

• the blood thinning drug warfarin

• sedatives or tranquilizers


Structured Label Content

Uses

• temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Section 42229-5 (42229-5)

Drug Facts

Purposes

Pain reliever

Nighttime sleep-aid

Warnings

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.

Directions

• do not take more than directed (see overdose warning)

adults and children 12 years of age and over: take 2 powders at bedtime, if needed, or as directed by a doctor. Drink a full glass of water with each dose, or may stir powder into a glass of water or other liquid.

do not give to children under 12 years of age

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.

• in children under 12 years of age

• with any other product containing diphenhydramine, even one used on skin

Other Information

• each powder contains: potassium 42 mg

• store below 25°C (77°F)

Overdose Warning: (Overdose warning:)

Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredients (Active ingredients)

(in each powder)

Acetaminophen 500 mg

Diphenhydramine Citrate 38 mg

Inactive Ingredients (Inactive ingredients)

citric acid, docusate sodium, fumaric acid, glycine, lactose monohydrate, magnesium stearate, potassium chloride, silica gel, sodium benzoate, sodium citrate dihydrate

Questions Or Comments? (Questions or comments?)

1-866-255-5197 

Principal Display Panel

Goody’s PM

Acetaminophen • Diphenhydramine Citrate

Pain Reliever/ Nighttime sleep-aid

FOR PAIN WITH SLEEPLESSNESS

16 Powder Packs

When Using This Product (When using this product)

• drowsiness will occur

• avoid alcoholic drinks

• be careful when driving a motor vehicle or operating 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 more than 10 days

• redness or swelling is present

• any new symptoms appear

These could be signs of a serious condition.

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health professional before use.

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

• liver disease

• glaucoma

• a breathing problem such as emphysema or chronic bronchitis

• trouble urinating due to an enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are Taking (Ask a doctor or pharmacist before use if you are taking)

• the blood thinning drug warfarin

• sedatives or tranquilizers


Advanced Ingredient Data


Raw Label Data

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