Label: GOODYS PM- acetaminophen and diphenhydramine citrate powder
- NDC Code(s): 63029-656-06, 63029-656-16
- Packager: Medtech Products Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated April 23, 2020
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- Active ingredients
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
• 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.
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.
• 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
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INGREDIENTS AND APPEARANCE
acetaminophen and diphenhydramine citrate powder
Product 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)