GOODYS PM - acetaminophen and diphenhydramine citrate powder
GlaxoSmithKline Consumer Healthcare LP

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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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

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

Goody's PM 16 count carton

GOODYS PM
acetaminophen and diphenhydramine citrate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10158-003
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (ACETAMINOPHEN)	ACETAMINOPHEN	500 mg
DIPHENHYDRAMINE CITRATE (DIPHENHYDRAMINE)	DIPHENHYDRAMINE CITRATE	38 mg

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE
DOCUSATE SODIUM
FUMARIC ACID
GLYCINE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POTASSIUM CHLORIDE
SILICON DIOXIDE
SODIUM BENZOATE
TRISODIUM CITRATE DIHYDRATE

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:10158-003-08	6 POWDER ( PACKET) in 1 PACKAGE	None
2	NDC:10158-003-09	8 POUCH ( POUCH) in 1 CARTON	contains a POUCH
2		2 POWDER ( PACKET) in 1 POUCH	This package is contained within the CARTON (10158-003-09)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	09/19/2011

Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 09/2011 GlaxoSmithKline Consumer Healthcare LP