EXCEDRIN BACK AND BODY- acetaminophen, aspirin tablet, film coated 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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.

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Drug Facts

Active ingredients (in each caplet)

Acetaminophen 250 mg

Buffered aspirin equal to 250 mg aspirin (NSAID)*

(buffered with calcium carbonate)

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever

Pain reliever

Uses

for the temporary relief of minor aches and pains due to:
minor pain of arthritis
backache
muscular aches

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
asthma (wheezing)
shock

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

more than 8 caplets 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

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

Do Not Use

if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
With any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if

you have liver disease
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

any other drug containing an NSAID (prescription or nonprescription)
a blood thinning (anticoagulant) or steroid drug
a prescription drug for diabetes, gout, or arthiritis
any other drug, or are under a doctor’s care for any serious condition

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
hoave bloody or black stools
o
have stomach pain that does not get better
ringing in the ears or loss of hearing occurs
painful area is red or swollen
pain gets worse or lasts for more than 10 days
fever gets worse or lasts for more than 3 days
any new symptoms appear

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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

do not use more than directed
drink a full glass of water with each dose
adults and children 12 years and over: take 2  caplets every 6 hours; not more than 8 caplets in 24 hours
children under 12 years: ask a doctor

Other information

each caplet contains: calcium 80 mg
store at controlled room temperature 20°-25°C (68°-77°F)
read all product information before using. Keep this box for important information.

Inactive ingredients

benzoic acid, D&C yellow #10 lake, FD&C blue #1 lake, FD&C blue #2 lake, hydroxypropylcellulose, hypromellose, maltodextrin, medium chain triglycerides, microcrystalline cellulose, polydextrose, polysorbate 80, povidone, pregelatinized starch, silicone dioxide, stearic acid, talc, zinc stearate

Questions or comments?

1-800-468-7746

Principal Display Panel

NDC 0067-6238-24

EXCEDRIN

BACK & BODY

EXTRA STRENGTH

Acetaminophen and Buffered Aspirin (NSAID)

Pain Reliever

See new warnings information

24 BI-LAYER CAPLETS

TAMPER-EVIDENT BOTTLE

DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH “SELAED for YOUR PROTECTION” IS BROKEN OR MISSING

Distributed by: Novartis Consumer Health, Inc.

Parsippany, NJ 07054-0622 USA

©2009

Visit us at www.excedrin.com

2005826A

Excedrin Back and Body 24 count carton
EXCEDRIN  BACK AND BODY
acetaminophen, aspirin tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-6238
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POVIDONES (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
ZINC STEARATE (UNII: H92E6QA4FV)  
Product Characteristics
ColorGREEN (Bi-layer Light & Dark Green) Scoreno score
ShapeCAPSULE (capsule-shaped tablet) Size18mm
FlavorImprint Code EBB
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-6238-061 in 1 CARTON02/15/201002/22/2016
16 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0067-6238-241 in 1 CARTON02/15/201002/22/2016
224 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:0067-6238-501 in 1 CARTON02/15/201002/22/2016
350 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:0067-6238-911 in 1 CARTON02/15/201002/22/2016
4100 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:0067-6238-771 in 1 CARTON02/15/201002/22/2016
5250 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:0067-6238-94100 in 1 BOTTLE; Type 0: Not a Combination Product02/15/201002/22/2016
7NDC:0067-6238-07250 in 1 BOTTLE; Type 0: Not a Combination Product02/15/201002/22/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34302/15/201002/22/2016
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 2/2017
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC