EXTRA STRENGTH ASPIRIN tablet

Extra Strength Aspirin by

Drug Labeling and Warnings

Extra Strength Aspirin by is a Otc medication manufactured, distributed, or labeled by Healthlife of USA, Time Cap Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug facts

Purpose

Pain reliever/ Fever reducer

Active ingredient (in each tablet)

Aspirin 325mg

Uses

Temporarily relieves minor aches and pains due to:

• headache
• muscular aches
• backache
• minor pain of arthritis
• the common cold
• 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 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: Aspirin may cause a 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

Do not use

• if you are allergic to aspirin, or any other pain reliever/fever reducer

Ask a doctor before use if 

• you have asthma 
• 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

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:

1. you experience any of the following signs of stomach bleeding:

• feel faint
• have bloody or black stools
• vomit blood
• have stomach pain that does not get better

2.   an allergic reaction occurs.

• seek medical help right away.

3.   ringing in the ears or loss of hearing occurs

4.   pain gets worse or lasts for more than 3 days

5.   redness or swelling present

6.   new symptoms occur

These could be sign 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 (1-800-222-1222) 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 take more than directed
• Drink a full glass of water with each dose 
• Adults and children 12 years of age and over: 

1. take 1 to 2 tablets every 4 hours while symptoms last
2. do not take more than 12 tablets in 24 hours unless directed by a doctor
3. do not use for more than 10 days unless directed by a doctor

• Children under 12 years: do not use unless directed by a doctor

Other Information

• Store at controlled room temperature 25°C (77°F) excursions permitted between 15-30°C (59-86°F)
• TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive ingredients

• Corn starch
• Croscarmellose sodium
• Hypromellose
• Microcrystalline cellulose
• Mineral oil
• Titanium dioxide

Questions or comments?

Call toll free 1-844-832-1138 Monday through Friday 9AM -5PM EST or www.healthlifeofusa.com

Extra Strength Aspirin Aspirin 325 mg 60 Tablets  Compare to Bayer® EXTRA STRENGTH active ingredients

Distributed by:
Healthlife of USA LLC
Rahway
NJ 07065
www.healthlifeofusa.com

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH ASPIRIN 
extra strength aspirin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69517-115
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69517-115-60	1 in 1 CARTON	05/31/2017
1		60 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	05/31/2017

Labeler - Healthlife of USA (079656178)

Establishment
Name	Address	ID/FEI	Business Operations
Healthlife of USA		079656178	relabel(69517-115)

Establishment
Name	Address	ID/FEI	Business Operations
Time Cap Laboratories, Inc.		037052099	manufacture(69517-115) , pack(69517-115)