EXTRA STRENGTH HEADACHE RELIEF- acetaminophen, aspirin, and caffeine capsule 
Walgreens

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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Extra Strength Headache Relief

Drug Facts

Active ingredients (in each softgel)Purposes
*
nonsteroidal anti-inflammatory drug
Acetaminophen 250 mgPain reliever
Aspirin 250 mg (NSAID) *Pain reliever
Caffeine 65 mgPain reliever aid

Uses

temporarily relieves minor aches and pains due to:

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:

  • skin reddening
  • blisters
  • 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:

  • 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 using this product
  • take more or for a longer time than directed

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

  • 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 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

  • a prescription drug for diabetes, gout, or arthritis
  • any other drug, or are under a doctor's care for any serious condition

Stop use and ask 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
  • 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 occur

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

Directions

Other information

Inactive ingredients

Beeswax, carboxymethyl cellulose, D&C Yellow No.10, ethanol, FD&C Blue No.1, gelatin, glycerin, HPMC, light liquid paraffin, PEG 400, purified water, shellac, sorbitol sorbitan solution, soya bean oil, soya lecithin, stearic acid, titanium dioxide

Questions or comments

1-888-333-9792

DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015

PRINCIPAL DISPLAY PANEL - 80 Softgel Bottle Label

NEW

Well at
Walgreens

NDC 0363-0021-80

EXTRA STRENGTH

Headache
Relief Softgels

Acetaminophen /
Aspirin (NSAID) /
Caffeine / Pain Reliever /
Pain Reliever Aid

80 SOFTGELS

Compare to Excedrin ® Extra Strength active ingredients ‡‡

PRINCIPAL DISPLAY PANEL - 80 Softgel Bottle Label
EXTRA STRENGTH HEADACHE RELIEF 
acetaminophen, aspirin, and caffeine capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0021
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
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX (UNII: 2ZA36H0S2V)  
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
ALCOHOL (UNII: 3K9958V90M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
WATER (UNII: 059QF0KO0R)  
SHELLAC (UNII: 46N107B71O)  
SORBITOL (UNII: 506T60A25R)  
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorgreenScoreno score
ShapeOVAL (OBLONG) Size21mm
FlavorImprint Code S08
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0021-8080 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/10/2016
Labeler - Walgreens (008965063)
Registrant - Spirit Pharmaceuticals LLC (179621011)
Establishment
NameAddressID/FEIBusiness Operations
Medgel Private LTD.677385498manufacture(0363-0021)

Revised: 12/2019
Document Id: 9af00e2c-7599-4bcf-e053-2995a90a96f9
Set id: a4463c1c-493c-4a86-ac4e-77671b7668ac
Version: 5
Effective Time: 20191230
 
Walgreens