Daytime Congestion Pressure and Pain: Package Insert and Label Information

DAYTIME CONGESTION PRESSURE AND PAIN- acetaminophen and phenylephrine hydrochloride capsule, liquid filled
PuraCap Pharmaceutical 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.

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

Daytime Congestion, Pressure & Pain 24 SOFTGELS

NDC 51013-408-04

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

Carton Label
(click image for full-size original)
DAYTIME CONGESTION PRESSURE AND PAIN
acetaminophen, phenylephrine hydrochloride capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51013-408
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE
PROPYLENE GLYCOL
WATER
SORBITOL
SORBITAN
Product Characteristics
Color orange (clear) Score no score
Shape capsule (oblong) Size 20mm
Flavor Imprint Code PC12
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51013-408-04 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK This package is contained within the CARTON (51013-408-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 04/06/2017
Labeler — PuraCap Pharmaceutical LLC (962106329)
Establishment
Name Address ID/FEI Operations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. 421293287 manufacture (51013-408), analysis (51013-408)

Revised: 01/2020 PuraCap Pharmaceutical LLC

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2020. All Rights Reserved.