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NDC 69842-0018-04 Daytime Congestion Pressure and Pain 325; 5 mg/1; mg/1 Details

Daytime Congestion Pressure and Pain 325; 5 mg/1; mg/1

Daytime Congestion Pressure and Pain is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by CVS PHARMACY, 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: 69842-0018-04
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: 69842-0018-04
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine

Product Information

NDC	69842-0018
Product ID	69842-018_2d3aa9a0-cabc-4b4b-9acd-9723873a1a74
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 Congestion Pressure and Pain
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	CVS PHARMACY, 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 69842-0018-04 (69842001804)

Pricing Information	N/A
NDC Package Code	69842-018-04
Billing NDC	69842001804
Package	2 BLISTER PACK in 1 CARTON (69842-018-04) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date	2017-04-13
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 14c5a143-83ec-45c4-a745-4ed706f58d5c Details

Active ingredients (in each softgel)

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Purpose

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

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.

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 yrs & over	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 yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution and white ink

Questions or comments?

Call toll free: 1-855-215-8180

PRINCIPAL DISPLAY PANEL - Carton Label

Daytime Congestion, Pressure & Pain 24 SOFTGELS

NDC 69842-018-04

*Compare to the active ingredients in Vicks® SinexTM Daytime Congestion, Pressure & Pain

INGREDIENTS AND APPEARANCE

DAYTIME CONGESTION PRESSURE AND PAIN

acetaminophen, phenylephrine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-018
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)
SORBITAN (UNII: 6O92ICV9RU)

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:69842-018-04	2 in 1 CARTON	04/13/2017
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	04/13/2017

Labeler - CVS PHARMACY, INC. (062312574)

Name	Address	ID/FEI	Business Operations
Establishment
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.		421293287	manufacture(69842-018) , analysis(69842-018)

Revised: 11/2019

Document Id: 2d3aa9a0-cabc-4b4b-9acd-9723873a1a74

Set id: 14c5a143-83ec-45c4-a745-4ed706f58d5c

Version: 3

Effective Time: 20191121