OTC Medication Information: Acetaminophen

ACETAMINOPHEN — acetaminophen tablet
TDS Pharm Co., Ltd

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.

Active Ingredients (in each tablet)


Acetaminophen 500mg

Purpose

Pain Reliever/fever reducer

Warnings

Liver Warning:

this product contains acetaminophen. Severe liver damage may occur if you take

  • more than 8 tablets in 24 hours, which is the maxium daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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

  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
These could be sign of a serious condition

If pregnant or breast-feeding

ask a health professional before use.

Keep out of reach of children.

Overdose warning:

Taking more than the recommended dose(overdose) may cause liver damage. 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 take more than directed (see overdose warning)

adults and children 12 years and over
  • take 2 tablets every 4 to 6 house as needed
  • do not take more than 8 tablets in 24 hours
  • do not use for more than 10 days unless directed by a doctor
children under 12 years do not use this adult Extra Strength product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Other Information

  • do not use if imprinted safety seal under cap is broken or missing.
  • Store at 15 ° — 30 ° C (59 ° — 86 ° F)
  • see end panel for lot number and expiration date

Inactive Ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, and sodium chloride

non-aspirin 50 tablet

image of carton label
(click image for full-size original)

Uses

temporarily relieves minor aches and pains due to:

  • headache
  • muscular aches
  • backache
  • arthritis
  • the common cold
  • toothache
  • mentrual cramps
  • temporarily reduces fever
ACETAMINOPHEN acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42912-0153
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (Acetaminophen) Acetaminophen 500 mg
Product Characteristics
Color white Score no score
Shape ROUND Size 13mm
Flavor Imprint Code A500
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42912-0153-6 1 BOTTLE (BOTTLE) in 1 BOX contains a BOTTLE
1 50 TABLET (TABLET) in 1 BOTTLE This package is contained within the BOX (42912-0153-6)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 08/01/2010
ACETAMINOPHEN acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42912-0152
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (Acetaminophen) Acetaminophen 500 mg
Product Characteristics
Color white Score no score
Shape CAPSULE Size 17mm
Flavor Imprint Code A500
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42912-0152-7 1 BOTTLE (BOTTLE) in 1 BOX contains a BOTTLE
1 40 TABLET (CAPSULE) in 1 BOTTLE This package is contained within the BOX (42912-0152-7)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 07/15/2010
Labeler — TDS Pharm Co., Ltd (689951176)
Registrant — TDS Pharm Co., Ltd (689951176)
Establishment
Name Address ID/FEI Operations
TDS Pharm Co., Ltd 689951176 manufacture

Revised: 06/2010 TDS Pharm Co., Ltd

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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