Goodys PM

Dosage form: powder
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE CITRATE 38mg
Labeler: GlaxoSmithKline Consumer Healthcare LP
NDC Code: 10158-003

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.

Drug Facts

Active ingredient (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

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 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.

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 powders 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

TAMPER EVIDENT FEATURE: DO NOT USE IF PACKET IS DAMAGED OR OPEN.

Distributed by:

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

©2011 GlaxoSmithKline

GOODY'S is a registered trademark of the GlaxoSmithKline group of companies.

TO OPEN CHILD-RESISTANT PACKAGE

1. Shake pack so powder settles on bottom.

2. Pinch and tear at either arrow or use scissors.

3. Tilt head back and pour powder onto tongue.

Principal Display Panel

NDC 10158-003-09

Goody's® PM

Acetaminophen • Diphenhydramine Citrate

Pain Reliever/Nighttime sleep-aid

NEW NO MESS PACK

FAST PAIN RELIEF

FOR PAIN WITH SLEEPLESSNESS

16 POWDER PACKS

100025XC

GOODYS  PM
acetaminophen and diphenhydramine citrate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10158-003
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
DIPHENHYDRAMINE CITRATE (DIPHENHYDRAMINE) DIPHENHYDRAMINE CITRATE38 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
DOCUSATE SODIUM 
FUMARIC ACID 
GLYCINE 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
POTASSIUM CHLORIDE 
SILICON DIOXIDE 
SODIUM BENZOATE 
TRISODIUM CITRATE DIHYDRATE 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:10158-003-086 POWDER in 1 PACKAGE
2NDC:10158-003-098 POUCH in 1 CARTON
22 POWDER in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34309/19/201112/31/2014
Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 09/2013
 
GlaxoSmithKline Consumer Healthcare LP

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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