Skip to Content

Dilotab II

Medically reviewed by Drugs.com. Last updated on Oct 28, 2020.

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

Further information

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

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