Goodys Headache Relief Shot

Dosage form: liquid
Ingredients: ACETAMINOPHEN 1000mg in 60mL, CAFFEINE 65mg in 60mL
Labeler: Medtech Products Inc.
NDC Code: 63029-639

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.

Goodys Headache Relief Shot

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 GoodysHeadacheReliefShot.com




PRINCIPAL DISPLAY PANEL

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




PRINCIPAL DISPLAY PANEL

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

GOODYS HEADACHE RELIEF SHOT 
acetaminophen and caffeine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-639
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN1000 mg  in 60 mL
CAFFEINE (CAFFEINE) CAFFEINE65 mg  in 60 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
GLYCERIN 
POTASSIUM CITRATE 
POTASSIUM SORBATE 
PROPYLENE GLYCOL 
WATER 
SUCRALOSE 
POVIDONE K29/32 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorCITRUSImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63029-639-012 BOTTLE, UNIT-DOSE (2 BOTTLE) in 1 DOSE PACK
160 mL in 1 BOTTLE, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34302/11/2013
GOODYS HEADACHE RELIEF SHOT 
acetaminophen and caffeine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-629
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN1000 mg  in 60 mL
CAFFEINE (CAFFEINE) CAFFEINE65 mg  in 60 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
GLYCERIN 
POTASSIUM CITRATE 
POTASSIUM SORBATE 
PROPYLENE GLYCOL 
WATER 
SUCRALOSE 
POVIDONE K29/32 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63029-629-012 BOTTLE, UNIT-DOSE (2 BOTTLE) in 1 DOSE PACK
160 mL in 1 BOTTLE, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34302/11/2013
Labeler - Medtech Products Inc. (122715688)
Establishment
NameAddressID/FEIOperations
Fareva Richmond, Inc.969523245MANUFACTURE(63029-639, 63029-629)

Revised: 02/2013
 
Medtech Products Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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