![EXCEDRIN MIGRAINE GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC]](https://medic.hrt.org//dailymed/images/cc2f4a6f-2a27-4a60-b5ef-ae0bb0988ff8/image-01.jpg)
| NDC | 0067-2035-16, 0067-2035-20, 0067-2035-24, 0067-2035-50, 0067-2035-80, 0067-2035-91 |
| Set ID | cc2f4a6f-2a27-4a60-b5ef-ae0bb0988ff8 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | NDA020802 |
- Active ingredients (in each geltab)
- Purposes
- Use
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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: Acetaminophen may cause severe skin reactions. Symptoms may include:
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- skin reddening
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- blisters
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- rash
If a skin reaction occurs, stop use and seek medical help right away.
Allergy alert: Aspirin may cause a severe allergic reaction which may include:
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- hives
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- facial swelling
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- asthma (wheezing)
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- shock
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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- more than 2 geltabs in 24 hours, which is the maximum daily amount
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- with other drugs containing acetaminophen
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- 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
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- are age 60 or older
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- have had stomach ulcers or bleeding problems
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- take a blood thinning (anticoagulant) or steroid drug
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- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
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- have 3 or more alcoholic drinks every day while using this product
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- take more or for a longer time than directed
Medication overuse headache warning: Headaches may worsen if this product is used for 10 or more days per month.
Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. 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
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- if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
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- 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
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- you have never had migraines diagnosed by a health professional
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- you have a headache that is different from your usual migraines
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- you have the worst headache of your life
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- you have fever and stiff neck
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- you have headaches beginning after or caused by head injury, exertion, coughing or bending
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- you experienced your first headache after the age of 50
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- you have daily headaches
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- you have a migraine so severe as to require bed rest
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- you have liver disease
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- stomach bleeding warning applies to you
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- you have a history of stomach problems, such as heartburn
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- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
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- you are taking a diuretic
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- you have asthma
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- you have problems or serious side effects from taking pain relievers or fever reducers
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- you have vomiting with your migraine headache
Ask a doctor or pharmacist before use if you are
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- taking a prescription drug for:
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- diabetes
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- gout
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- arthritis
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- under a doctor’s care for any serious condition
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- taking any other drug
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- taking any other product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer
Stop use and ask a doctor if
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- an allergic reaction occurs. Seek medical help right away.
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- you experience any of the following signs of stomach bleeding:
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- feel faint
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- vomit blood
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- have bloody or black stools
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- have stomach pain that does not get better
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- your migraine is not relieved or worsens after first dose
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- new or unexpected symptoms occur
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- ringing in the ears or loss of hearing occurs
- Keep out of reach of children.
- Directions
- Other information
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Inactive ingredients
benzoic acid, D&C yellow no. 10 aluminum lake, edetate disodium, FD&C blue no. 1, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, ferrosoferric oxide, gelatin, glycerin, hypromellose, isopropyl alcohol, lactose monohydrate, light mineral oil, low-substituted hydroxypropyl cellulose, maltitol solution, medium-chain triglycerides, microcrystalline cellulose, pepsin, polysorbate 20, povidone, propyl gallate, propylene glycol, simethicone, sorbitan monolaurate, stearic acid, titanium dioxide
- Questions?
- Additional Information
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
EXCEDRIN MIGRAINE GELTABS
acetaminophen, asprin, caffeine tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-2035 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg Inactive Ingredients Ingredient Name Strength BENZOIC ACID (UNII: 8SKN0B0MIM) D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C BLUE NO. 1--ALUMINUM LAKE (UNII: J9EQA3S2JM) FD&C RED NO. 40 (UNII: WZB9127XOA) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) ISOPROPYL ALCOHOL (UNII: ND2M416302) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) LIGHT MINERAL OIL (UNII: N6K5787QVP) LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 2165RE0K14) MALTITOL (UNII: D65DG142WK) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) PEPSIN (UNII: GID333S43J) POLYSORBATE 20 (UNII: 7T1F30V5YH) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYL GALLATE (UNII: 8D4SNN7V92) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DIMETHICONE (UNII: 92RU3N3Y1O) SORBITAN MONOLAURATE (UNII: 6W9PS8B71J) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color GREEN (dark green) , WHITE Score no score Shape ROUND Size 18mm Flavor Imprint Code E Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0067-2035-20 1 in 1 CARTON 09/13/2011 1 20 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0067-2035-24 1 in 1 CARTON 09/13/2011 12/31/2014 2 24 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:0067-2035-50 1 in 1 CARTON 09/13/2011 12/31/2014 3 50 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:0067-2035-80 1 in 1 CARTON 09/13/2011 4 80 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:0067-2035-91 2 in 1 CARTON 09/13/2011 12/31/2014 5 100 in 1 BOTTLE; Type 0: Not a Combination Product 6 NDC:0067-2035-16 2 in 1 CARTON 09/13/2011 12/31/2014 6 160 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020802 09/13/2011 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
