Extra Strength Headache Relief: Package Insert and Label Information

EXTRA STRENGTH HEADACHE RELIEF- acetaminophen, aspirin and caffeine tablet, coated
Spirit Pharmaceuticals 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.

Drug Facts

Active Ingredient (in each tablet)

Acetaminophen

Aspirin

Caffeine

Purpose

Pain reliever

Pain reliever

Pain reliever aid

Uses

• temporarily relieves minor aches and pains due to: • headache • a cold • arthritis • muscular aches • sinusitis • 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. 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 tablets 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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 heartbeat.

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 non-prescription) • a prescription drug for diabetes, gout or arthritis • any other drug,
or are under a doctor’s care for any serious condition • a blood thinning (anticoagulant) or steroid drug

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 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. 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.

Overdose warning:

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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 (see Overdose warning) • drink a full glass of water with each dose • adults and children 12 years and over: take 2 tablets every 6 hours; not more than 8 tablets in 24 hours • children under 12 years: ask a doctor

Other Information

• store at controlled room temperature 20°-25° C (68°-77° F) • read all product information before using

Inactive ingredients

Colloidal silicon dioxide, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, talc

Questions or comments?

1-888-333-9792

Distributed by:

Cabinet Health P.B.C.

Pouch

ES Headache Pouch
(click image for full-size original)

EXTRA STRENGTH HEADACHE RELIEF
acetaminophen, aspirin, and caffeine tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-4183
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
SILICON DIOXIDE
HYPROMELLOSES
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE
STARCH, POTATO
STEARIC ACID
TALC
Product Characteristics
Color white Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code S53
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68210-4183-3 30 TABLET, COATED in 1 POUCH None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 11/19/2021
Labeler — Spirit Pharmaceuticals LLC (179621011)
Registrant — Spirit Pharmaceuticals LLC (179621011)
Establishment
Name Address ID/FEI Operations
Elysium Pharmaceuticals Ltd 915664486 manufacture (68210-4183)

Revised: 11/2021 Spirit Pharmaceuticals LLC

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