GOODYS BACK AND BODY- acetaminophen liquid

GOODYS by

Drug Labeling and Warnings

GOODYS by is a Otc medication manufactured, distributed, or labeled by Medtech Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Goody’s®
Back & Body Pain Relief

1000 mg Acetaminophen
PAIN RELIEVER/ FEVER REDUCER

SINGLE DOSE
2 FL OZ (60 mL)

Drug Facts

Active ingredient (per 60 mL)

Acetaminophen 1000 mg

Purpose

Pain reliever/ Fever reducer

Use

Temporarily relieves minor aches and pains due to:

• headache
  
• muscle aches
  
• cold and flu
  
• toothache
  
• minor arthritis pain
  
• back ache

Temporarily reduces fever.

Warnings

Liver warning:
This product contains acetaminophen. Severe liver damage may occur if

you 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

Ask a doctor before use if you have

liver disease.

Ask a doctor or pharmacist before use if

you are taking the blood thinning drug warfarin.

Stop use and ask a doctor if

• pain gets worse or lasts more than 10 days
  
• fever gets worse or lasts more than 3 days
  
• new symptoms occur
  
• redness or swelling is present

If pregnant or breastfeeding,

ask a healthcare professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical even if you do not notice any signs or symptoms.

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

Other information

• store at room temperature
  
• read all product information before using

Inactive ingredients

citric acid, flavor, glycerin, polyvinylpyrrolidone, potassium citrate, potassium sorbate, propylene glycol, purified water, sucralose

Questions?

1-866-255-5197 goodyspowder.com

Tamper Evident: Do not use if printed shrink band on bottle is broken or missing.

©2015 Distributed by Medtech Products Inc.
Tarrytown, NY 10591, a Prestige Brands Company

PRINCIPAL DISPLAY PANEL

Goody’s
Back & Body
Pain Relief
1,000 MG Acetaminophen
Pain Reliever/ Fever Reducer
2 FL OZ (60 mL)

INGREDIENTS AND APPEARANCE

GOODYS  BACK AND BODY
acetaminophen liquid

Product 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
1		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 63029-620-04	2 in 1 CARTON
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)