NDC | 63029-661-01, 63029-661-02 |
Set ID | db5d6c2b-688e-4e88-a42d-0fa2b0d8140b |
Category | HUMAN OTC DRUG LABEL |
Packager | Medtech Products Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART341 |
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purposes
- Uses
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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 productAllergy 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 skinAsk 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 glandAsk a doctor or pharmacist before use if you are taking
• the blood thinning drug warfarin
• sedatives or tranquilizersWhen using this product
• drowsiness will occur
• avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machineryStop 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.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.
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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
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
GOODYS PM
acetaminophen and diphenhydramine citrate powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-656 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg DIPHENHYDRAMINE CITRATE (UNII: 4OD433S209) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE CITRATE 38 mg Inactive Ingredients Ingredient Name Strength 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 Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63029-656-06 6 in 1 CARTON; Type 0: Not a Combination Product 09/01/2013 2 NDC:63029-656-16 16 in 1 CARTON; Type 0: Not a Combination Product 09/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 09/01/2013 Labeler - Medtech Products Inc. (122715688)