DOLOGESIC DF- acetaminophen, phenyltoloxamine citrate tablet

Dologesic by

Drug Labeling and Warnings

Dologesic by is a Otc medication manufactured, distributed, or labeled by LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (in each caplet)               Purpose

Acetaminophen ............................. 500 mg .......... Analgesic

Phenyltoloxamine Citrate ............... 30 mg ............ Hay fever relief

PURPOSE

Uses

• For the temporary relief of minor aches and pains associated with
• headache
• muscular aches
• backaches
• minor arthritis pain
• common cold
• toothaches
• menstrual cramps
• temporarily reduces fever
• itchy and watery eyes due to hay fever
  

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
  

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

Ask a doctor before use:

• if you have liver disease
• if you are taking the thinning drug warfarin

Stop using this product and ask doctor if:

• 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.
  

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

Keep out of reach of children.

PREGNANCY OR BREAST FEEDING

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

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

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

Inactive Ingredients: Povidone, pregelatinized starch, stearic acid, magnesium stearate, silicon dioxide.

QUESTIONS

Questions or Comments?1-866-595-5598

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DOLOGESIC  DF
acetaminophen, phenyltoloxamine citrate tablet

Product 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)