GOODYS PM- acetaminophen and diphenhydramine citrate powder 
Medtech Products Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Goodys PM

Drug Facts

Active ingredients

(in each powder)
Acetaminophen 500 mg
Diphenhydramine Citrate 38 mg

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

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.

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.

Keep out of reach of children.

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.

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 42 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 

Principal Display Panel

Goody’s PM
Acetaminophen • Diphenhydramine Citrate
Pain Reliever/ Nighttime sleep-aid
FOR PAIN WITH SLEEPLESSNESS
16 Powder Packs

Principal Display Panel
Goody’s PM
Acetaminophen • Diphenhydramine Citrate
Pain Reliever/ Nighttime sleep-aid
FOR PAIN WITH SLEEPLESSNESS
16 Powder Packs

Principal Display Panel
Goody’s PM
Acetaminophen • Diphenhydramine Citrate
Pain Reliever/ Nighttime sleep-aid
FOR PAIN WITH SLEEPLESSNESS
16 Powder Packs

Principal Display Panel
Goody’s PM
Acetaminophen • Diphenhydramine Citrate
Pain Reliever/ Nighttime sleep-aid
FOR PAIN WITH SLEEPLESSNESS
16 Powder Packs

Principal Display Panel
Goody’s PM
Acetaminophen • Diphenhydramine Citrate
Pain Reliever/ Nighttime sleep-aid
FOR PAIN WITH SLEEPLESSNESS
16 Powder Packs

Principal Display Panel
Goody’s PM
Acetaminophen • Diphenhydramine Citrate
Pain Reliever/ Nighttime sleep-aid
FOR PAIN WITH SLEEPLESSNESS
16 Powder Packs

Principal Display Panel
Goody’s PM
Acetaminophen • Diphenhydramine Citrate
Pain Reliever/ Nighttime sleep-aid
FOR PAIN WITH SLEEPLESSNESS
16 Powder Packs

GOODYS PM 
acetaminophen and diphenhydramine citrate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-656
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
DIPHENHYDRAMINE CITRATE (UNII: 4OD433S209) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE CITRATE38 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
FUMARIC ACID (UNII: 88XHZ13131)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
GLYCINE (UNII: TE7660XO1C)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-656-066 in 1 CARTON; Type 0: Not a Combination Product09/01/2013
2NDC:63029-656-1616 in 1 CARTON; Type 0: Not a Combination Product09/01/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34109/01/2013
Labeler - Medtech Products Inc. (122715688)

Revised: 4/2020
Document Id: 6ce73cc3-08a0-41b2-9a9f-24a040ce2ef5
Set id: db5d6c2b-688e-4e88-a42d-0fa2b0d8140b
Version: 4
Effective Time: 20200423
 
Medtech Products Inc.