Label: DOLOGESIC- acetaminophen, phenyltoloxamine citrate, alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 54859-512-06 - Packager: Llorens Pharmaceutical International Division
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated June 19, 2012
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ACTIVE INGREDIENT
Active Ingredients in each tablespoonful (15 mL) Purpose
Acetaminophen, USP .................... 500 mg/15mL......................Pain Reliever/Fever Reducer
Phenyltoloxamine Citrate, USP ........ 30 mg/15mL......................Pain Reliever
Alcohol, USP....................................... 5%...............................Pharmaceutical Aid
- PURPOSE
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WARNINGS
Alcohol Warning:If you consumer 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers.
Acetaminophen may cause liver damage.
When using this product
- drowsiness may occur
- avoid alcoholic beverages
- alcohol and sedatives may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
Ask a doctor before use if you are
- taking tranquilizers or sedatives
- glaucoma
- emphysema
- asthma
- chronic pulmonary disease
- trouble urinating due to an enlarged prostate gland
- pain persists for more than 10 days, or redness is present, or in conditions affecting children 12 years of age, consult a physician immediately
- if relief does not occur within 3 days, discontinue use and consult a physician
- DO NOT USE
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
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DOSAGE & ADMINISTRATION
Directions Do not exceed 8 tablespoons in any 24-hour period or as directed by a doctor
adults and children 12 years of age and older
take 1 or 2 tablespoons every 4 to 6 hours
children under 12 years of age
Consult a physician; do not give this product to children
under 12 years of age. This product will provide more than the
recommended dose (overdose) of non-aspirin and could cause
serious health problems
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DOLOGESIC
acetaminophen, phenyltoloxamine citrate, alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54859-512 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg in 15 mL PHENYLTOLOXAMINE CITRATE (UNII: 8UE48MJH8M) (PHENYLTOLOXAMINE - UNII:K65LB6598J) PHENYLTOLOXAMINE CITRATE 30 mg in 15 mL ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.75 mL in 15 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MENTHOL (UNII: L7T10EIP3A) METHYLPARABEN (UNII: A2I8C7HI9T) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SUCROSE (UNII: C151H8M554) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54859-512-06 177 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 09/01/1994 Labeler - Llorens Pharmaceutical International Division (037342305)