VALUMEDS ASPIRIN- aspirin tablet, delayed release

VALUMEDS ASPIRIN by

Drug Labeling and Warnings

VALUMEDS ASPIRIN by is a Otc medication manufactured, distributed, or labeled by SPIRIT PHARMACEUTICALS LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Aspirin (NSAID)* 325 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

INDICATIONS & USAGE

• temporary relieves minor aches and pains due to: 
• headache 
• minor arthritis pain
• toothache
• menstrual pain
• colds
•  or as recommended by a doctor

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:

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

Stomach bleeding warning:  This product contains an 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.

Do not use

if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer

Ask a doctor before use if

• 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 phamracist before use if you are

taking a prescription drug for diabetis, gout or arthritis

Stop use and ask a doctor if

• 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
• pain gets worse or lasts more than 10 days
• redness or swelling is present
• any new symptom appear
• ringing in the ears or a loss of hearing occurs

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. 1(800)222-1222

Directions

• adults and children 12 years of age and over: take 1 to 2 tablets every 4 hours, while symptoms persist. Drink a full glass of water with each dose.
•  do not take more than 12 tablets in 24 hours unless directed by a doctor
•  children under 12 years of age: ask a doctor

Other information

• store below 25 0C (77 0F)
• Tampet Evident Feature: Do not use if printed inner-seal beneath cap is missing or broken

INACTIVE INGREDIENT

corn starch, croscarmellose sodium,D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose,mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc,titanium dioxide, triethyl citrate

Questions or comments?

1(888)333-9792

PRINCIPAL DISPLAY PANEL

VALUMEDS TM

Compare to the active ingredient in

ECOTRIN ® TABLETS*

REGULAR STRENGTH

ASPIRIN

PAIN RELIEVER (NSAID)

SAFETY COATED
PROTECT AGAINST

STOMACH UPSET

100 TABLETS

INGREDIENTS AND APPEARANCE

VALUMEDS ASPIRIN 
aspirin tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68210-2500
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
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	T
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68210-2500-1	1 in 1 CARTON	03/10/2020
1		100 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	03/10/2020

Labeler - SPIRIT PHARMACEUTICALS LLC (179621011)

Registrant - Spirit Pharmaceuticals LLC (179621011)

Establishment
Name	Address	ID/FEI	Business Operations
TIME CAP LABORATORIES, INC.		037052099	manufacture(68210-2500)