DAYTIME SINUS AND CONGESTION- acetaminophen, phenylephrine hydrochloride capsule, liquid filled

DAYTIME SINUS AND CONGESTION by

Drug Labeling and Warnings

DAYTIME SINUS AND CONGESTION by is a Otc medication manufactured, distributed, or labeled by Chain Drug Consortium, LLC, Accucaps Industries Limited, Accucaps Industries Limited Strathoy, Legacy Pharmaceutical Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient(s)

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/Fever reducer

Nasal decongestant

Uses

• temporarily relieves symptoms due to common cold
• minor aches and pains
• headache
• fever
• nasal congestion
• sinus congestion & pressure
• temporarily relieves symptoms due to hay fever or other upper respiratory allergies
• minor aches and pains
• headache
• nasal congestion
• sinus congestion & pressure

Warnings

Liver warning: This product contains acetaminophen.

 Severe liver damage may occur if you take

• more than 4 doses in 24 hours, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Do not use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.   
• 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.

Ask a doctor before use if you have

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

When using this product, do not use more than directed.

Stop use and ask a doctor if

• pain or nasal congestion gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• you get nervous, dizzy or sleepless

If pregnant or breast-feeding, 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• take only as directed
• do not exceed 4 doses per 24 hrs 

• adults & children 12 yrs & over: 2 Liquid Caps with water every 4 hrs
• children 4 to under 12 yrs: ask a doctor
• children under 4 yrs: do not use

Other information

• store at controlled room temperature 15°C to 30°C (59°F to 86°F)

Inactive ingredients

edible white ink, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water and sorbitol

Questions or comments?

1-800-706-5575

*This product is not manufactured or distributed by Procter & Gamble, distributor of Vicks® QlearQuilTM DayTime Sinus & Congestion Liquicaps®.

Principal Display Panel

Premier Value

Non-Drowsy

Daytime

Sinus & Congestion

NDC number 68016-630-16

16 Liquid Capsule

INGREDIENTS AND APPEARANCE

DAYTIME SINUS AND CONGESTION  
acetaminophen, phenylephrine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-630
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
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POVIDONE K12 (UNII: 333AG72FWJ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE	Score	no score
Shape	CAPSULE	Size	16mm
Flavor		Imprint Code	48A
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-630-16	8 in 1 BLISTER PACK
1		2 in 1 CARTON; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/13/2015

Labeler - Chain Drug Consortium, LLC (101668460)

Establishment
Name	Address	ID/FEI	Business Operations
Accucaps Industries Limited		248441727	analysis(68016-630) , manufacture(68016-630)

Establishment
Name	Address	ID/FEI	Business Operations
Accucaps Industries Limited Strathoy		243944050	analysis(68016-630) , manufacture(68016-630)

Establishment
Name	Address	ID/FEI	Business Operations
Legacy Pharmaceutical Packaging		969852743	pack(68016-630)