NITETIME SINUS RELIEF- acetaminophen, phenylephrine hydrochloride, doxylamine succinate capsule, liquid filled

NiteTime Sinus Relief by

Drug Labeling and Warnings

NiteTime Sinus Relief by is a Otc medication manufactured, distributed, or labeled by PuraCap Pharmaceutical LLC, Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 symptoms due to the common cold
• minor aches and pains
• headache
• fever
• runny nose and sneezing
• nasal congestion
• sinus congestion & pressure
• temporarily relieves symptoms due to hay fever or other upper respiratory allergies
• minor aches and pains
• headache
• runny nose and sneezing
• nasal congestion
• itching of the nose or throat, and itchy, watery eyes
• 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 daily while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

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.
• to make a child sleep  

Ask a doctor before use if you have

• liver disease
• heart disease
• thyroid disease
• diabetes
• high blood pressure
• glaucoma
• a breathing problem such as emphysema or chronic bronchitis
• trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin

When using this product

• do not use more than directed
• excitability may occur, especially in children
• marked drowsiness may occur
• avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery
• alcohol, sedatives and tranquilizers may increase drowsiness

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 & 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 and children 12 yrs & over:

  take 2 softgels 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 room temperature 15°-30°C (59°-86°F)

Inactive ingredients

FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, white edible ink

Questions or comments?

Call toll free: 1-855-215-8180

PRINCIPAL DISPLAY PANEL

Nite Time Sinus Relief 24 SOFTGELS

NDC: 51013-156-04

Compare to Vicks® QlearQuil Nighttime Sinus & Congestion active ingredients*

INGREDIENTS AND APPEARANCE

NITETIME SINUS RELIEF 
acetaminophen, phenylephrine hydrochloride, doxylamine succinate capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51013-156
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	blue (clear)	Score	no score
Shape	capsule (oblong)	Size	20mm
Flavor		Imprint Code	PC13
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51013-156-04	2 in 1 CARTON	07/26/2016
1		12 in 1 BLISTER PACK; 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	07/26/2016

Labeler - PuraCap Pharmaceutical LLC (962106329)

Establishment
Name	Address	ID/FEI	Business Operations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd		421293287	manufacture(51013-156) , analysis(51013-156)