Active Ingredients
(in each powder)
Acetaminophen 500 mg
Diphenhydramine Citrate 38 mg
Goodys Pm Powder
FDA Label NDC 63029-656
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Medtech Products Inc. for the product Goodys Pm (NDC 63029-656). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purposes, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are taking, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Pain reliever
Nighttime sleep-aid
Uses
• temporary 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 4,000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product
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
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
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.
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 right away. 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 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
Other Information
• each powder contains: potassium 55 mg
• store below 25°C (77°F)
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 (English/Spanish) weekdays
Principal Display Panel
Goody’s PM
Acetaminophen • Diphenhydramine Citrate
Pain Reliever/ Nighttime sleep-aid
FOR PAIN WITH SLEEPLESSNESS
16 Powder Packs
Goody’s Pmacetaminophen • Diphenhydramine Citratepain Reliever/ Nighttime Sleep-aidfor Pain With Sleeplessness16 Powder Packs (Goodys Pm 01)
Principal Display Panel
Goody’s PM
Acetaminophen • Diphenhydramine Citrate
Pain Reliever/ Nighttime sleep-aid
FOR PAIN WITH SLEEPLESSNESS
6 Powder Packs
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