NDC 0031-8721 Robitussin Peak Cold Daytime Cold Plus Flu

NDC Product Code 0031-8721

NDC 0031-8721-02

Package Description: 30 POUCH in 1 CARTON > 2 CAPSULE, LIQUID FILLED in 1 POUCH

NDC 0031-8721-20

Package Description: 20 BLISTER PACK in 1 CARTON > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Robitussin Peak Cold Daytime Cold Plus Flu with NDC 0031-8721 is a product labeled by Richmond Division Of Wyeth. The generic name of Robitussin Peak Cold Daytime Cold Plus Flu is . The product's dosage form is and is administered via form.

Labeler Name: Richmond Division Of Wyeth

Dosage Form: -

Product Type: 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.

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 RED NO. 40 (UNII: WZB9127XOA)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • POVIDONE K12 (UNII: 333AG72FWJ)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SORBITAN (UNII: 6O92ICV9RU)
  • SORBITOL (UNII: 506T60A25R)
  • MINERAL OIL (UNII: T5L8T28FGP)

Product Labeler Information

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

Labeler Name: Richmond Division Of Wyeth
Labeler Code: 0031
Start Marketing Date: 04-15-2012 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: 12-31-2019 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: I 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. Values = ‘Y’ or ‘N’.

* 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]
Dextromethorphan

Dextromethorphan is pronounced as (dex troe meth or' fan)
Why is dextromethorphan medication prescribed?
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat th...
[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.

Robitussin Peak Cold Daytime Cold Plus Flu Product Label Images

Robitussin Peak Cold Daytime Cold Plus Flu 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

Distributed by: Pfizer, Madison, NJ 07940 USAMade in CanadaFor most recent product information, visit www.robitussin.com

Otc - Purpose

Active ingredients (in each liquid-filled capsule)PurposesAcetaminophen, USP 325 mgPain reliever/Fever reducerDextromethorphan HBr, USP 10 mgCough suppressantPhenylephrine HCl, USP 5 mgNasal decongestant

Uses

  • Temporarily relieves these symptoms occurring with a cold or flu:headachenasal congestionsore throatcoughminor aches and painstemporarily reduces fever

Liver Warning

  • This product contains acetaminophen. Severe liver damage may occur if you takemore than 12 capsules in any 24-hour period, which is the maximum daily amountwith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this product

Sore Throat Warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do Not Use

  • 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.with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask A Doctor Before Use If You Have

  • Liver diseaseheart diseasehigh blood pressurethyroid diseasediabetestrouble urinating due to an enlarged prostate glandcough that occurs with too much phlegm (mucus)a chronic cough that lasts or as occurs with smoking, asthma, or emphysema

Ask A Doctor Or Pharmacist Before Use If You Are

  • Taking the blood thinning drug warfarintaking any other oral nasal decongestant or stimulanttaking any other pain reliever/fever reducer

Otc - When Using

When using this product do not use more than directed

Stop Use And Ask A Doctor If

  • You get nervous, dizzy, or sleeplesspain, cough, or nasal congestion gets worse or lasts more than 7 daysfever gets worse or lasts more than 3 daysredness or swelling is presentcough comes back or occurs with rash or headache that lasts.These could be signs of a serious condition.new symptoms occur

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. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

Directions

  • Do not take more than 12 capsules in any 24-hour perioddo not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.this adult product is not intended for use in children under 12 years of ageagedoseadults and children 12 years and over2 capsules every 4 hourschildren under 12 yearsdo not use

Other Information

  • Store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).

Inactive Ingredients

FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, mineral oil, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution

* Please review the disclaimer below.