GOODYS HEADACHE RELIEF SHOT- acetaminophen and caffeine liquid

Goodys Headache Relief Shot by

Drug Labeling and Warnings

Goodys Headache Relief Shot 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

Drug Facts

Active ingredients

(per 60 mL)

Acetaminophen 1000 mg

Caffeine 65 mg

Purpose

Pain reliever/ Pain Reliever Aid

Use

Temporarily relieves minor aches and pains due to:

• headache
• sore throat
• minor arthritis pain
• muscle aches
• cold and flu
• toothache

Warnings

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

you take

• more than 4 Headache Relief Shots™ 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

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Caffeine warning: This product contains caffeine. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.

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 Headache Relief Shot every 6 hours while symptoms persist; do not take more than 4 Headache Relief Shots 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

PRINCIPAL DISPLAY PANEL

NDC- 63029-629-01
Goody’s Headache Relief Shot
2 Pack
Citrus

PRINCIPAL DISPLAY PANEL

NDC- 63029-639-01
Goody’s Headache Relief Shot
2 Pack
Berry

INGREDIENTS AND APPEARANCE

GOODYS HEADACHE RELIEF SHOT 
acetaminophen and caffeine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-639
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
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg  in 60 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
POVIDONE K29/32 (UNII: 390RMW2PEQ)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	CITRUS	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-639-01	2 in 1 DOSE PACK	02/11/2013
1		60 mL in 1 BOTTLE, UNIT-DOSE; 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	02/11/2013

GOODYS HEADACHE RELIEF SHOT 
acetaminophen and caffeine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-629
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
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg  in 60 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
POVIDONE K29/32 (UNII: 390RMW2PEQ)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-629-01	2 in 1 DOSE PACK	02/11/2013
1		60 mL in 1 BOTTLE, UNIT-DOSE; 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	02/11/2013

Labeler - Medtech Products Inc. (122715688)

Establishment
Name	Address	ID/FEI	Business Operations
Fareva Richmond, Inc.		969523245	MANUFACTURE(63029-639, 63029-629)