- 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
-
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)