STANBACK- aspirin and caffeine powder

Stanback by

Drug Labeling and Warnings

Stanback 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 ingredient

(in each powder)

Aspirin (NSAID*) 845 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Active ingredient

(in each powder)

Caffeine 65 mg

Purpose

Pain reliever aid

Uses

• temporarily relieves minor aches and pains due to:
  • headache
    
  • muscular aches
    
  • minor arthritis pain
    
  • colds
  
  
• temporarily reduces fever

Warnings

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction which may include:

• hives
  
• facial swelling
  
• shock
  
• asthma (wheezing)

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

• are age 60 or older
  
• have had stomach ulcers or bleeding problems
  
• take a blood thinning (anticoagulant) or steroid drug
  
• take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  
• have 3 or more alcoholic drinks every day while using this product
  
• take more or for a longer time than directed

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

if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer

Ask a doctor before use if

• stomach bleeding warning applies to you
  
• you have a history of stomach problems, such as heartburn
  
• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  
• you are taking a diuretic
  
• you have asthma

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

• diabetes
  
• gout
  
• arthritis

Stop use and ask a doctor if

• an allergic reaction occurs. Seek medical help right away.
  
• you experience any of the following signs of stomach bleeding:
  • feel faint
    
  • vomit blood
    
  • have bloody or black stools
    
  • have stomach pain that does not get better
  
  
• pain gets worse or lasts more than 10 days
  
• fever gets worse or lasts more than 3 days
  
• redness or swelling is present
  
• any new symptoms appear
  
• ringing in the ears or a loss of hearing occurs

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health care professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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.

Directions

• adults and children 12 years of age and over: place 1 powder on tongue every 6 hours, while symptoms persist. Drink a full glass of water with each dose, or may stir powder into a glass of water or other liquid.
  
• do not take more than 4 powders in 24 hours unless directed by a doctor.
  
• children under 12 years of age: ask a doctor.

Other information

• each powder contains: potassium50 mg
  
• store below 25ºC (77ºF)

Inactive ingredients

docusate sodium, fumaric acid, lactose monohydrate, potassium chloride

Questions?

1-866-255-5197 

PRINCIPAL DISPLAY PANEL

STANBACK

ASPIRIN (NSAID) - PAIN RELIEVER

CAFFEINE - PAIN RELIEVER AID

50 POWDERS

INGREDIENTS AND APPEARANCE

STANBACK 
aspirin and caffeine powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-501
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	845 mg

Inactive Ingredients
Ingredient Name	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0)
FUMARIC ACID (UNII: 88XHZ13131)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-501-01	50 in 1 CARTON; Type 0: Not a Combination Product	10/01/2012
2	NDC: 63029-501-02	2 in 1 PACKAGE; Type 0: Not a Combination Product	10/01/2012
3	NDC: 63029-501-06	6 in 1 PACKAGE; Type 0: Not a Combination Product	10/01/2012
4	NDC: 63029-501-24	24 in 1 CARTON; Type 0: Not a Combination Product	10/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	10/01/2012

Labeler - Medtech Products Inc. (122715688)