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Name:Apap 500
Manufacturer:Cypress Pharmaceutical, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


APAP 500

APAP 500  - acetaminophen liquid 
Cypress Pharmaceutical, Inc.

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.

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APAP 500

Drug Facts

Active ingredient                                     Purpose
(in each 5 mL teaspoonful)
Acetaminophen, USP 500 mg ..... Pain reliever/fever reducer

Uses

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

Warnings

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take:
  • more than 8 teaspoonfuls (40 mL) in 24 hours, which is the maximum daily amount.
  • any other drug containing acetaminophen.
  • 3 or more alcoholic drinks every day while using this product.

Ask a doctor before use

if you have health issues especially liver disease.

Ask a doctor or pharmacist before use

if you are taking other drugs, including the blood thinner warfarin.

Do not use

  • with any other product containing acetaminophen (prescription or non-prescription). 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.

Stop use and ask a doctor if

  • new symptoms occur such as rash, hives, itching or hoarseness
  • 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 signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention
is critical even if you do not notice any signs or symptoms.

Directions

Do not exceed recommended dosage.
Overdose Warnings: Taking more than the recommended dose (overdose) can cause serious health problems,
including liver damage.

  • adults and children 12 years of age and older: take 2 teaspoonfuls (10 mL) every 6 hours; do not exceed 8 teaspoonfuls (40 mL) in 24 hours
  • not recommended for children under that age of 12: this adult strength product will provide more than the recommended dose (overdose), and may cause liver damage

Other Information

Store at controlled room temperature, 15o-30oC (59o-86oF).
This product contains 9 mg of sodium per teaspoonful (5 mL).

Inactive Ingredients

cherry flavor, citric acid, FD and C Blue #1, FD and C Red #40, glycerin, methylparaben, polyethylene glycol,
propylparaben, purified water, sodium citrate, sodium saccharin.

Questions?

1-800-856-4393 M-F (8 a.m. to 5 p.m. CST), or directly to Medwatch at 1-800-332-1088.
Serious side effects associated with use of this product may be reported to this number.

PRODUCT PACKAGING:

The packaging below represents the labeling currently used:

Principal Display Panel for 237 mL Label:

NDC 60258-050-08
MAXIMUM STRENGTH
APAP 500
(Acetaminophen Oral Solution, USP)
500 mg/5 mL
Adult Liquid
Pain Reliever / Fever Reducer
Sugar Free / Alcohol Free
Aspirin Free
CHERRY FLAVOR

Cypress Pharmaceutical, Inc.

8 fl oz (237 mL)

See New Warnings Information

Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing,

Distributed by:
Cypress Pharmaceutical, Inc.
Madison, MS 39110
L678 Rev. 01/10


APAP 500 Packaging

APAP 500 Packaging


APAP 500 
acetaminophen oral solution liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:60258-050
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (Acetaminophen) Acetaminophen 500 mg  in 5 mL
Product Characteristics
Color      Score     
Shape Size
Flavor CHERRY Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60258-050-08 237 mL in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 06/15/1995

Labeler - Cypress Pharmaceutical, Inc. (790248942)

Revised: 02/2010 Cypress Pharmaceutical, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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