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Goodys

GlaxoSmithKline Consumer Healthcare LP

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Acetaminophen 500 mg

Diphenhydramine Citrate 38 mg

Pain reliever

Nighttime sleep-aid

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

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.

  • 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
  • each powder contains: potassium 55 mg
  • •store below 25°C (77°F)

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

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

acetaminophen and diphenhydramine citrate POWDER

Product Information

Product Type Human otc drug label Item Code (Source) NDC:10158-003
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 500 mg
DIPHENHYDRAMINE CITRATE DIPHENHYDRAMINE 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

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:10158-003-08 6 in 1 PACKAGE
2 2 in 1 POUCH
3 NDC:10158-003-09 8 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2011-09-19


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Be sure to consult your doctor before taking any medication!
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