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

Extra Strength Headache Relief by

Drug Labeling and Warnings

Extra Strength Headache Relief by is a Otc medication manufactured, distributed, or labeled by Walgreens, Spirit Pharmaceuticals LLC , Medgel Private LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

Uses

temporarily relieves minor aches and pains due to:

• headache
• a cold
• arthritis
• muscular aches
• toothache
• premenstrual & menstrual cramps

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

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

Other information

• store at 20° - 25° C (68° - 77° F)
• close cap tightly after use
• read all product information before using.

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

SPL UNCLASSIFIED SECTION

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 ‡‡

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH HEADACHE RELIEF 
acetaminophen, aspirin, and caffeine capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0021
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
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
Color	green	Score	no score
Shape	OVAL (OBLONG)	Size	21mm
Flavor		Imprint Code	S08
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0021-80	80 in 1 BOTTLE; Type 0: Not a Combination Product	08/10/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	08/10/2016

Labeler - Walgreens (008965063)

Registrant - Spirit Pharmaceuticals LLC (179621011)

Establishment
Name	Address	ID/FEI	Business Operations
Medgel Private LTD.		677385498	manufacture(0363-0021)