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ACETAMINOPHEN by SPIRIT PHARMACEUTICALS LLC

Medically reviewed on May 15, 2017

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg
Labeler: SPIRIT PHARMACEUTICALS LLC
NDC Code: 68210-0022

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.

VALUMEDS REGULAR STRENGTH PAIN RELIEF

Drug facts

Active ingredient (in each tablet)

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Uses
  • temporarily relieves minor aches and pains due to:
  • the common cold
  • headache
  • backache
  • minor pain of arthritis
  • toothache
  • muscular aches
  • premenstrual and menstrual cramps
  • temporarily reduces fever

Warnings

Liver warning

This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. 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 drugs every day while using this product

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.

Do not use
  • 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 are allergic to acetaminophen or any of the inactive ingredients in this product.

Ask a doctor before use if you have liver disease

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Stop use and ask a doctor if
  • pain gets worse or lasts more than 10 days in adults
  • pain gets worse or lasts more than 5 days in children under 12 years
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

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 take more than directed (see overdose warning)

 adults and children 12 years and over
  •  take 2 tablets every 4 to 6 hours while symptoms last
  • do not take more than 10 tablets in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor
 children 6 years to under 12 years
  •  take 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours
  • do not use for more than 5 days unless directed by a doctor
 children under 6 years    ask a doctor

Other information
  • store between 20-25°C (68-77°F)
  • do not use if carton is opened or neck wrap or foil inner seal imprinted with "SAFETY SEAL" is broken or missing

Inactive ingredients

povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions or comments?

1-888-333-9792

Distributed By

Spirit Pharmaceuticals, LLC

Ronkonkoma, NY 11779

PRINCIPAL DISPLAY PANEL - 100 Tablets bottle

VALUMEDS

Compare to the active ingredient in

Regular Strength Tylenol®*

REGULAR STRENGTH

PAIN

RELIEF

ACETAMINOPHEN 325 mg

PAIN RELIVER/

FEVER REDUCER

100 TABLETS

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-0022
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE 
STARCH, PREGELATINIZED CORN 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize10mm
FlavorImprint CodeTCL340
Contains    
Packaging
#Item CodePackage Description
1NDC:68210-0022-1100 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34305/19/2017
Labeler - SPIRIT PHARMACEUTICALS LLC (179621011)
Establishment
NameAddressID/FEIOperations
TIME-CAP LABS INC037052099manufacture(68210-0022)

 
SPIRIT PHARMACEUTICALS LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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