FAIRFIELD HEALTH PRODUCTS EXTRA STRENGTH- acetaminophen, aspirin, caffeine tablet, film coated

FAIRFIELD HEALTH PRODUCTS EXTRA STRENGTH by

Drug Labeling and Warnings

FAIRFIELD HEALTH PRODUCTS EXTRA STRENGTH by is a Otc medication manufactured, distributed, or labeled by Fairfield Health Products Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

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      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 behaviour 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

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 warnings: 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 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

 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 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 occur

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health care 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 of age and over: take 2 caplets every 6 hours: not more than 8 caplets in 24 hours
• under 12 years: ask a doctor

Other information

 store at 20°C - 25°C (68° - 77°)
 read all product information before using. Keep this box for important information.

Inactive ingredients

benzoic acid, carnauba wax, FD&C blue#1, hydroxypropylcelluose, hypromellose, light mineral oil, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone emulsion, sorbitanmonolaurate, stearic acid, titanium dioxide

Questions or comments?

1-(973) 276-0740

SPL UNCLASSIFIED SECTION

Has the same Active Ingredient as in Excedrin Extra Strength

Distributed by Fairfield Health Products LLC

Packaging

INGREDIENTS AND APPEARANCE

FAIRFIELD HEALTH PRODUCTS EXTRA STRENGTH 
acetaminophen, aspirin, caffeine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73689-101
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)
CARNAUBA WAX (UNII: R12CBM0EIZ)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIMETHICONE (UNII: 92RU3N3Y1O)
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	capsule	Size	18mm
Flavor		Imprint Code	F
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73689-101-02	25 in 1 BOX	03/12/2020
1	NDC: 73689-101-01	2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	03/12/2020

Labeler - Fairfield Health Products Llc (117430712)