Search

STANBACK (aspirin and caffeine) powder
[GlaxoSmithKline Consumer Healthcare LP]


NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKEDTED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.

Active ingredients (in each powder)

Aspirin (NSAID*) 845 mg

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

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

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, or arthritis

When using this product

Limit the use of caffeine-containing drugs, foods, or drinks because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.

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:
o
feel faint
o
vomit blood
o
have bloody or black stools
o
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 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 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: potassium 55 mg
store below 25oC (77oF)

Inactive ingredients

docusate sodium, fumaric acid, lactose monohydrate, potassium chloride

Questions or comments?

1-866-255-5197 (English/Spanish) weekdays

Principal Display Panel

NDC 0135-0499-50

STANBACK®

SNAP BACK WITH STANBACK®

Headache Powders

ASPIRIN (NSAID) - PAIN RELIEVER - FEVER REDUCER

CAFFEINE - PAIN RELIEVER AID

RELIEVES PAIN FAST

FOR TEMPORARY RELIEF OF MINOR ACHES & PAIN DUE TO

HEADACHES - BODY ACHES

ARTHRITIS - COLDS & FEVER

50 POWDERS

TAMPER EVIDENT FEATURE: DO NOT USE IF SAFETY OVERWRAP OR "S" TEAR-TAPE IS MISSING OR TORN.

Distributed by: GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

©2011 GlaxoSmithKline

STANBACK AND SNAP BACK WITH STANBACK are registered trademarks of the GlaxoSmithKline group of companies.

30643XD

Stanback Label

INGREDIENTS & APPEARANCE

STANBACK 
aspirin and caffeine powder
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0135-0499
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN845 mg
CAFFEINE (CAFFEINE) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
DOCUSATE SODIUM 
FUMARIC ACID 
LACTOSE MONOHYDRATE 
POTASSIUM CHLORIDE 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0499-066 in 1 PACKAGE
2NDC:0135-0499-2424 in 1 CARTON
3NDC:0135-0499-5050 in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34306/08/201012/31/2014
Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 11/2013
 
GlaxoSmithKline Consumer Healthcare LP