Headache Relief Extra Strength: Package Insert and Label Information

HEADACHE RELIEF EXTRA STRENGTH- acetaminophen, aspirin and caffeine tablet, film coated
WinCo Foods, 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.

Active ingredients (in each caplet)

Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever
Pain reliever
Pain reliever aid

Uses

• temporarily relieves minor aches and pains due to:
  • headache
  • arthritis
  • a cold
  • muscular aches
  • toothache
  • premenstrual and 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: Aspirin may cause a severe allergic reaction, which may include:

• shock
• facial swelling
• hives
• asthma (wheezing)

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.

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

• more than 4,000 mg of acetaminophen in 24 hours
• 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
• 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
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• 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.
• if you have ever had an allergic reaction to this product or any of its ingredients

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 have asthma
• you are taking a diuretic

Ask a doctor or pharmacist before use if you are

• taking a prescription drug for diabetes, gout, or arthritis
• taking 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:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
• ringing in the ears or a loss of hearing occurs

• redness or swelling is present

• pain gets worse or lasts for more than 10 days
• fever gets worse or lasts for more than 3 days
• 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 at 20 weeks or later in 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 accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• do not take 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. Do not take more than 8 caplets in 24 hours.
• children under 12 years: ask a doctor

Other information

• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• see end flap for expiration date and lot number

Inactive ingredients

corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide

Questions?

Call 1-800-824-1706 Monday — Friday 9am-4pm MST

Principal Display Panel

WinCo®
FOODS

EXTRA STRENGTH
Headache
Relief

**Compare to the active ingredients
in EXCEDRIN® Extra Strength

Relieves: Minor Aches & Pains

ACETAMINOPHEN,
ASPIRIN (NSAID) / PAIN RELIEVER
CAFFEINE/PAIN RELIEVER AID

100
Caplets

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704

** This product is not manufactured or distributed
by GSK CONSUMER HEALTHCARE SARL,
distributor of EXCEDRIN® Extra Strength.

100% SATISFACTION GUARANTEE Comments & Questions? 800-824-1706

50844 REV1121E33412 WF2204

Winco 44-334

HEADACHE RELIEF EXTRA STRENGTH acetaminophen, aspirin, caffeine tablet, film coated

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67091-112 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 250 mg ASPIRIN (ASPIRIN) ASPIRIN 250 mg CAFFEINE (CAFFEINE) CAFFEINE 65 mg

Inactive Ingredients Ingredient Name Strength STARCH, CORN CROSPOVIDONE, UNSPECIFIED HYPROMELLOSE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE POVIDONE, UNSPECIFIED PROPYLENE GLYCOL SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID TITANIUM DIOXIDE

Product Characteristics Color white Score no score Shape OVAL Size 17mm Flavor Imprint Code 44;334 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:67091-112-10 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC 1 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (67091-112-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 03/13/2008

Labeler — WinCo Foods, LLC (056098817)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		038154464	pack (67091-112)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		832867837	manufacture (67091-112)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		832867894	manufacture (67091-112)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		967626305	pack (67091-112)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		117025878	manufacture (67091-112)

Revised: 05/2023 WinCo Foods, LLC