Dilotab II description, usages, side effects, indications, overdosage, supplying and lots more!

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Dilotab II

Zee Medical Inc
Ultra Seal Corporation

Drug Facts




FULL PRESCRIBING INFORMATION

Active ingredient

Active Ingredient (in each tablet)  Acetaminophen 325 mg, Phenylephrine HCL-Nasal Decongestant

Purpose

Purpose-Pain Reliever  Nasal Decongestant

Uses

Uses temporarily relieves the following cold and hay fever symptoms:
■ nasal and sinus congestion ■ sinus pain ■ headache ■ minor aches and pains
Warnings

Directions
■ adults: take 2 tablets every 4 hours, not more than 12 tablets in 24 hours

Children under 12 years, ask a doctor


Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
■ more than 12 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
■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or
emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your
prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains
acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if you have
■ heart disease ■ high blood pressure ■ diabetes ■ thyroid disease ■ liver disease
■ trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Stop use and ask a doctor if
■ you get nervous, dizzy or sleepless
■ pain or nasal congestion gets worse or lasts more than 7 days
■ redness or swelling is present in the painful area
■ any new symptoms appear

If pregnant or breast-feeding baby, 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 for adults as well as for  
children even if you do not notice any signs or symptoms.

Inactive Ingredients:corn starch, FDC blue 1 aluminum lake, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid

MM1Dilotab II1

Dilotab II

Acetaminophen Phenylephrine TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:35418-136
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
POVIDONE K29/32
STARCH, CORN
STEARIC ACID
SODIUM STARCH GLYCOLATE TYPE A POTATO
FD&C BLUE NO. 1
cellulose, microcrystalline

Product Characteristics

Color Size Imprint Code Shape
blue (sky blue) 11 mm ZEE;DT2 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:35418-136-02 2 in 1 PACKET
2 NDC:35418-136-67 125 in 1 CARTON
3 NDC:35418-136-68 50 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2012-06-12


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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