NDC 37000-508 Sinex

Acetaminophen, Doxylamine Succinate, And Phenylephrine Hydrochloride

NDC Product Code 37000-508

NDC CODE: 37000-508

Proprietary Name: Sinex What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Acetaminophen, Doxylamine Succinate, And Phenylephrine Hydrochloride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
TURQUOISE (C48334)
Shape: OVAL (C48345)
Size(s):
21 MM
Imprint(s):
VS;NIGHT
Score: 1

NDC Code Structure

  • 37000 - The Procter & Gamble Manufacturing Company

NDC 37000-508-24

Package Description: 12 BLISTER PACK in 1 CARTON > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

NDC Product Information

Sinex with NDC 37000-508 is a a human over the counter drug product labeled by The Procter & Gamble Manufacturing Company. The generic name of Sinex is acetaminophen, doxylamine succinate, and phenylephrine hydrochloride. The product's dosage form is capsule, liquid filled and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1052647.

Dosage Form: Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Sinex Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • POVIDONES (UNII: FZ989GH94E)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: The Procter & Gamble Manufacturing Company
Labeler Code: 37000
FDA Application Number: part341 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 07-29-2016 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Information for Patients

Acetaminophen

Acetaminophen is pronounced as (a set a mee' noe fen)

Why is acetaminophen medication prescribed?
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to va...
[Read More]
Doxylamine

Doxylamine is pronounced as (dox il' a meen)
Why is doxylamine medication prescribed?
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 ot...
[Read More]
Phenylephrine

Phenylephrine is pronounced as (fen il ef' rin)
Why is phenylephrine medication prescribed?
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 ...
[Read More]

* Please review the disclaimer below.

Sinex Product Label Images

Sinex Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts

DIST. BY PROCTER & GAMBLE,


CINCINNATI, OH 45202.

Otc - Purpose

Active ingredients (in each LiquiCap)PurposeAcetaminophen 325 mgPain reliever/Fever reducerDoxylamine succinate 6.25 mgAntihistaminePhenylephrine HCl 5 mgNasal decongestant

Uses

  • Temporarily relieves symptoms due to the common cold
  • Minor aches and painsheadachefeverrunny nose and sneezingnasal congestionsinus congestion & pressuretemporarily relieves symptoms due to hay fever or other upper respiratory allergies
  • Minor aches and painsheadacherunny nose and sneezingitching of the nose or throat, and itchy, watery eyesnasal congestionsinus congestion & pressure

Liver Warning

  • This product contains acetaminophen.Severe liver damage may occur if you takemore than 4 doses in 24 hours, which is the maximum daily amount for this productwith other drugs containing acetaminophen3 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

Ask A Doctor Before Use If You Have

  • Liver diseaseheart diseasethyroid diseasediabeteshigh blood pressureglaucomaa breathing problem such as emphysema or chronic bronchitistrouble urinating due to enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

  • Taking sedatives or tranquilizerstaking the blood thinning drug warfarin

When Using This Product

  • Do not use more than directed excitability may occur, especially in childrenmarked drowsiness may occuravoid alcoholic drinksbe careful when driving a motor vehicle or operating machineryalcohol, sedatives & tranquilizers may increase drowsiness

Stop Use And Ask A Doctor If

  • Pain or nasal congestion gets worse or lasts more than 7 daysfever gets worse or lasts more than 3 daysredness or swelling is presentnew symptoms occuryou get nervous, dizzy or sleepless

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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 directeddo not exceed 4 doses per 24 hrsadults & children 12 yrs & over2 LiquiCaps with water every 4 hrschildren 4 to under 12 yrsask a doctorchildren under 4 yrsdo not use

Other Information

  • Store at room temperature

Inactive Ingredients

FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

* Please review the disclaimer below.