Label: STANBACK- aspirin and caffeine powder
- NDC Code(s): 63029-501-01, 63029-501-02, 63029-501-06, 63029-501-24
- Packager: Medtech Products Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 25, 2024
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- Active ingredient
- Purpose
- Active ingredient
- Purpose
- Uses
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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
- feel faint
- 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.
- hives
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Directions
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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.
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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.
- Other information
- Inactive ingredients
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
STANBACK
aspirin and caffeine powderProduct 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:63029-501-24 24 in 1 CARTON; Type 0: Not a Combination Product 10/01/2012 3 NDC:63029-501-02 2 in 1 PACKAGE; Type 0: Not a Combination Product 10/01/2012 4 NDC:63029-501-06 6 in 1 PACKAGE; 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 Drug M013 10/01/2012 Labeler - Medtech Products Inc. (122715688)
