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NDC 63868-0464-48 Daytime Sinus Relief and Nighttime Sinus Relief Details

Daytime Sinus Relief and Nighttime Sinus Relief

Daytime Sinus Relief and Nighttime Sinus Relief is a KIT in the HUMAN OTC DRUG category. It is labeled and distributed by Chain Drug Marketing Association Inc.. The primary component is .

MedlinePlus Drug Summary

Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Related Packages: 63868-0464-48
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen

Doxylamine is used in the short-term treatment of insomnia (difficulty falling asleep or staying asleep). Doxylamine is also used in combination with decongestants and other medications to relieve sneezing, runny nose, and nasal congestion caused by the common cold. Doxylamine should not be used to cause sleepiness in children. Doxylamine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 63868-0464-48
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Doxylamine

Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.

Related Packages: 63868-0464-48
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine

Product Information

NDC	63868-0464
Product ID	63868-464_6f600ad5-ad1f-479f-9754-1dc6746a60aa
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Daytime Sinus Relief and Nighttime Sinus Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	acetaminophen, doxylamine succinate, phenylephrine hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	KIT
Route	n/a
Active Ingredient Strength	n/a
Active Ingredient Units	n/a
Substance Name	n/a
Labeler Name	Chain Drug Marketing Association Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63868-0464-48 (63868046448)

Pricing Information	N/A
NDC Package Code	63868-464-48
Billing NDC	63868046448
Package	1 KIT in 1 CARTON (63868-464-48) * 4 BLISTER PACK in 1 CARTON / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 2 BLISTER PACK in 1 CARTON / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date	2017-04-12
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d538445e-a47d-4983-844f-38aa303d11fd Details

Active ingredients for Nighttime Sinus (in each softgel)

Acetaminophen 325 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Active ingredients for Daytime Sinus (in each softgel)

Acetaminophen 325 mg

Phenylephrine hydrochloride 5 mg

Purposes

Nighttime Sinus Relief

Pain reliever/Fever reducer

Antihistamine

Nasal decongestant

Purposes

Daytime Sinus Relief

Pain reliever/Fever reducer

Nasal decongestant

Uses

temporarily relieves symptoms due to the common cold
- minor aches and pains
- headache
- fever
- runny nose and sneezing (Nighttime only)
- 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 (Nighttime only)
- itching of the nose or throat, and itchy, watery eyes (Nighttime only)
- nasal congestion
- sinus congestion & pressure

Warnings

Liver warning

These products contain acetaminophen. Severe liver damage may occur if you take

more than 10 softgels 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.
to make a child sleep (Nighttime only)

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers (Nighttime only)
taking the blood thinning drug warfarin

When using this product

do not use more than directed, in addition when using Nighttime Sinus and Congestion:
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 & tranquilizers may increase drowsiness

Stop use and ask a doctor if

pain or nasal congestion gets worse or last 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 hours

Age	Daytime Sinus	Nighttime Sinus
adults and children 12 years and over	2 softgels with water every 4 hours	2 softgels with water every 4 hours
children 4 to under 12 years	ask a doctor	ask a doctor
children under 4 years	do not use	do not use

Other information

store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat

Inactive ingredients

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

Daytime Sinus: FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, white edible ink

Questions or comments?

Call 248-449-9300

Principal Display Panel

CDMA Daytime Sinus Relief and Nighttime Sinus Relief 48 SOFTGELS

NDC 63868-464-48

Compare to the active ingredients in Vicks® QlearQuilTM Daytime Sinus & Congestion and Nighttime Sinus & Congestion*

INGREDIENTS AND APPEARANCE

DAYTIME SINUS RELIEF AND NIGHTTIME SINUS RELIEF

acetaminophen, doxylamine succinate, phenylephrine hydrochloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63868-464

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63868-464-48	1 in 1 CARTON; Type 0: Not a Combination Product	04/12/2017

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	4 BLISTER PACK	32
Part 2	2 BLISTER PACK	16

Part 1 of 2
DAYTIME SINUS RELIEF acetaminophen, phenylephrine hydrochloride capsule, liquid filled

Product Information
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
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	orange (clear)	Score	no score
Shape	capsule (oblong)	Size	20mm
Flavor		Imprint Code	PC12
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		4 in 1 CARTON
1		8 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	04/12/2017

Part 2 of 2
NIGHTTIME SINUS RELIEF acetaminophen, doxylamine succinate, phenylephrine hydrochloride capsule, liquid filled

Product Information
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		2 in 1 CARTON
1		8 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	04/12/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	04/12/2017

Labeler - Chain Drug Marketing Association Inc. (011920774)

Name	Address	ID/FEI	Business Operations
Establishment
Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd		421293287	manufacture(63868-464) , analysis(63868-464)

Revised: 12/2019

Document Id: 6f600ad5-ad1f-479f-9754-1dc6746a60aa

Set id: d538445e-a47d-4983-844f-38aa303d11fd

Version: 2

Effective Time: 20191230

Search by Drug Name or NDC

NDC 63868-0464-48 Daytime Sinus Relief and Nighttime Sinus Relief Details

Daytime Sinus Relief and Nighttime Sinus Relief

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 63868-0464-48 (63868046448)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL d538445e-a47d-4983-844f-38aa303d11fd Details

Active ingredients for Nighttime Sinus (in each softgel)

Active ingredients for Daytime Sinus (in each softgel)

Purposes

Purposes

Uses

Warnings

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

Directions

Other information

Inactive ingredients

Questions or comments?

Principal Display Panel

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