Label: DOLOGESIC DF- acetaminophen, phenyltoloxamine citrate tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 54859-110-10 - Packager: LLORENS PHARMACEUTICALS 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 April 10, 2012
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
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WARNINGS
Warnings
Alcohol Warning:If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers/
Liver Warning: This product contains Acetaminophen, Sever liver damage may occur if you take
- more than 6 tablets in 24 hours,which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
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DO NOT USE
Do not use
- with any other drug 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 the product
- for more than 10 days for pain, unless directed by a doctor
- for more than 3 days for fever, unless directed by a doctor
- if you have liver disease
- if you are taking the thinning drug warfarin
- pain gets worse or lasts more than 10 days
- 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.
- with any other drug containing acetaminophen (prescription or non-prescription).
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WHEN USING
Warnings:
- May cause drowsiness: alcohol, sedatives and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product
- Do not take this product if you are taking sedatives or tranquilizers without consulting a doctor
- Use caution when driving motor vehicles or operating machinery
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
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DOSAGE & ADMINISTRATION
Directions: Do not exceed recommended dosage
AGE
Dose
adults and children 12 years of age and over
take 1 tablet every 4-6 hours.
Do not take more than 6 tablets in 24 hours,
or as directed by a doctor
children under 12 years of age
Do not use in children under 12 years of age.
This will provide more than the recommended dose
(overdose) of acetaminophen and could cause liver damage
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INDICATIONS & USAGE
Overdose Warning:Taking more than the recommended dose (overdose), may cause liver damage. In case of accidental overdose, contact a physician or Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Other information:Store at room temperature 15-30 degrees C (59-86 degrees F).
Tamper Evident: Do not use if there is evidence of tampering.
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DOLOGESIC DF
acetaminophen, phenyltoloxamine citrate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54859-110 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg PHENYLTOLOXAMINE CITRATE (UNII: 8UE48MJH8M) (PHENYLTOLOXAMINE - UNII:K65LB6598J) PHENYLTOLOXAMINE CITRATE 30 mg Inactive Ingredients Ingredient Name Strength POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color white Score no score Shape OVAL Size 20mm Flavor Imprint Code LLORENS Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54859-110-10 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 09/01/2009 Labeler - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305)
