Label: GOODYS BACK AND BODY- acetaminophen liquid
- NDC Code(s): 63029-620-02, 63029-620-04
- Packager: Medtech Products Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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.
Drug Label Information
Updated June 22, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (per 60 mL)
- Purpose
- Use
-
Warnings
Liver warning:
This product contains acetaminophen. Severe liver damage may occur ifyou take
- more than 3 full (60 mL) bottles in 24 hours, which is the maximum daily amount
- 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 non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
- more than 3 full (60 mL) bottles in 24 hours, which is the maximum daily amount
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Directions
- do not take more than directed (see overdose warning)
- adults and children 12 years of age and over: take one full (60 mL) bottle every 6 hours while symptoms persist; do not take more than 3 full (60 mL) bottles in 24 hours.
- children under 12 years of age: ask a doctor
- do not take more than directed (see overdose warning)
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
GOODYS BACK AND BODY
acetaminophen liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-620 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 1000 mg in 60 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) POVIDONE K29/32 (UNII: 390RMW2PEQ) POTASSIUM CITRATE (UNII: EE90ONI6FF) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color Score Shape Size Flavor ORANGE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63029-620-02 1 in 1 CARTON 08/01/2015 1 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:63029-620-04 2 in 1 CARTON 08/01/2015 2 60 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 08/01/2015 Labeler - Medtech Products Inc. (122715688)
