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Dilotab II

Medically reviewed by Drugs.com. Last updated on Oct 28, 2021.

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Zee Medical Inc
NDC Code: 35418-136

Drug Facts

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

Purpose-Pain Reliever  Nasal Decongestant

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

DILOTAB II 
acetaminophen phenylephrine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35418-136
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE K29/32 
STARCH, CORN 
STEARIC ACID 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
FD&C BLUE NO. 1 
CELLULOSE, MICROCRYSTALLINE 
Product Characteristics
Colorblue (sky blue) Scoreno score
ShapeROUND (ZEE;DT2) Size11mm
FlavorImprint CodeZEE;DT2
Contains    
Packaging
#Item CodePackage Description
1NDC:35418-136-6850 CARTON in 1 CARTON
1NDC:35418-136-67125 PACKET in 1 CARTON
1NDC:35418-136-022 TABLET in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34306/12/2012
Labeler - Zee Medical Inc (009645623)
Registrant - Ultra Seal Corporation (085752004)
Establishment
NameAddressID/FEIOperations
Ultratab Laboratories, Inc.151051757manufacture(35418-136)
Establishment
NameAddressID/FEIOperations
Ultra Seal Corporation085752004repack(35418-136)

 
Zee Medical Inc

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.