NIGHT TIME SINUS- acetaminophen, doxylamine succinate, and phenylephrine hydrochloride capsule, liquid filled
Chain Drug Consortium, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUG FACTS

Active ingredients (in each softgel)

Acetaminophen 325 mg

Doxylamine Succinate 6.25 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/ fever reducer

Antihistamine

Nasal decongestant

Uses

temporarily relieves nasal & sinus symptoms:

sinus pain
nasal & sinus congestion
headache
runny nose and sneezing

Warnings

This product contains acetaminophen. Severe liver damage may occur if you take:

more than 6 doses in 24 hrs, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks daily while using this product

Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly

Overdose warning: Taking more than directed can cause serious health problems.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults and for children even if you do not notice any signs or symptoms

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
thyroid disease
diabetes
high blood pressure
glaucoma
difficulty in urinating due to an enlarged prostate gland
a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

When using this product

do not exceed recommended dosage
marked drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives & tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in children

Stop use and ask a doctor if

redness or swelling is present
you get nervous, dizzy or sleepless
fever gets worse or lasts more than 3 days
new symptoms occur
symptoms do not get better within 7 days or are accompanied by a fever. These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Directions

take every 4 hours
do not take more than 6 doses in 24 hours
do not use more than directed (see Overdose warning)
when using other night- time and day- time products, carefully read each label to ensure correct dosing

adults and children 12 years of age and older	swallow 2 softgels with water
children 4 to 12 years of age	ask a doctor
children under 4 years of age	do not use

Other information

store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
this product does not contain penylpropanolamine (PPA)
*this product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® Nyquil® Sinus

Inactive ingredients

bone gelatin, FD&C Blue No. 1, glycerin USP, polyethylene glycol 400 NF, povidone K12PF, propylene glycol USP, purified water, sorbitol special, and white edible ink.

Principal Display Panel

Multi- Symptom

Night- Time sinus Liquid capsules

Relieves:

Sinus headache

pain

congestion

Acetaminophen, Doxylamine succinate, Phenylephrine HCl

Pain reliever/ fever reducer, antihistamine, nasal decongestant

Distributed by:

Chain Drug Consortium, LLC

2300 NW Corporate blvd., suite 115

Boca Raton, FL 33431

Call toll free 1-877-753-3935

SEE NEW WARNINGS INFORMATION

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

PRINCIPAL DISPLAY PANEL - 24 Capsule Carton

Night time sinus

NIGHT TIME SINUS
acetaminophen, doxylamine succinate, and phenylephrine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68016-101
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	BLUE	Score	no score
Shape	CAPSULE	Size	20mm
Flavor		Imprint Code	47A
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68016-101-12	1 in 1 CARTON	07/13/2010	12/01/2017
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	07/13/2010	12/01/2017

Labeler - Chain Drug Consortium, LLC (101668460)

Revised: 7/2019

Document Id: 2292107c-fe8e-4fdd-aee2-4049e06f7e56

Set id: 8fb2af75-7ab2-4152-9d1c-64530d6d0df6

Version: 5

Effective Time: 20190715

Chain Drug Consortium, LLC