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NDC 63868-0463-24 DayTime Sinus 325; 5 mg/1; mg/1 Details

DayTime Sinus 325; 5 mg/1; mg/1

DayTime Sinus is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by Chain Drug Marketing Association Inc.. The primary component is ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE.

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: 63868-0463-24
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen

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: 63868-0463-24
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine

Product Information

NDC	63868-0463
Product ID	63868-463_f26a4f1f-ba77-4701-9a51-dc928c1c2cfd
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
Proprietary Name Suffix	n/a
Non-Proprietary Name	acetaminophen, phenylephrine hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE, LIQUID FILLED
Route	ORAL
Active Ingredient Strength	325; 5
Active Ingredient Units	mg/1; mg/1
Substance Name	ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Labeler Name	Chain Drug Marketing Association Inc.
Pharmaceutical Class	Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63868-0463-24 (63868046324)

Pricing Information	N/A
NDC Package Code	63868-463-24
Billing NDC	63868046324
Package	2 BLISTER PACK in 1 CARTON (63868-463-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date	2017-04-12
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b22e7d6e-a481-46e0-8fcc-c5e9c479e0ee Details

Active ingredients (in each softgel)

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Purposes

Pain reliever/Fever reducer

Nasal decongestant

Uses

temporarily relieves symptoms due to the 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 daily 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 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 & 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 years and over	2 softgels with water every 4 hours.
children 4 to under 12 years	ask a doctor
children under 4 years	do not use

Other information

store at room temperature 15°-30°C (59°-86°F)

Inactive ingredients

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

Questions or comments?

Call248-449-9300

PRINCIPAL DISPLAY PANEL

DayTime Sinus 24 SOFTGELS

NDC 63868-463-24

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

INGREDIENTS AND APPEARANCE

DAYTIME SINUS

acetaminophen, phenylephrine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63868-463
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
Packaging
1	NDC:63868-463-24	2 in 1 CARTON	04/12/2017
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	04/12/2017

Labeler - Chain Drug Marketing Association Inc. (011920774)

Name	Address	ID/FEI	Business Operations
Establishment
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.		421293287	manufacture(63868-463) , analysis(63868-463)

Revised: 12/2019

Document Id: f26a4f1f-ba77-4701-9a51-dc928c1c2cfd

Set id: b22e7d6e-a481-46e0-8fcc-c5e9c479e0ee

Version: 2

Effective Time: 20191230