DILOTAB II- acetaminophen phenylephrine tablet

Dilotab II by

Drug Labeling and Warnings

Dilotab II by is a Otc medication manufactured, distributed, or labeled by Zee Medical Inc, Ultratab Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

Purpose-Pain Reliever  Nasal Decongestant

INDICATIONS & USAGE

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

DOSAGE & ADMINISTRATION

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

Children under 12 years, ask a doctor

WARNINGS

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding baby, ask a health professional  
before use

KEEP OUT OF REACH OF CHILDREN

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DILOTAB II 
acetaminophen phenylephrine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35418-136
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
POVIDONE K29/32 (UNII: 390RMW2PEQ)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	blue (sky blue)	Score	no score
Shape	ROUND (ZEE;DT2)	Size	11mm
Flavor		Imprint Code	ZEE;DT2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35418-136-68	50 in 1 CARTON	06/12/2012
1	NDC: 35418-136-67	125 in 1 CARTON
1	NDC: 35418-136-02	2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	06/12/2012

Labeler - Zee Medical Inc (009645623)

Registrant - Ultra Seal Corporation (085752004)

Establishment
Name	Address	ID/FEI	Business Operations
Ultratab Laboratories, Inc.		151051757	manufacture(35418-136)

Establishment
Name	Address	ID/FEI	Business Operations
Ultra Seal Corporation		085752004	repack(35418-136)