NDC 64525-0547 Premier Value Day Time Severe Cold And Cough Berry Infused With Menthol And Green Tea Flavors

NDC Product Code 64525-0547

NDC CODE: 64525-0547

Proprietary Name: Premier Value Day Time Severe Cold And Cough Berry Infused With Menthol And Green Tea Flavors 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: 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):
RED (C48326 - FD & C RED NO. 40)
BLUE (C48333 - FD & C BLUE NO.1)
Flavor(s):
BERRY (C73365 - BERRY INFUSED WITH MENTHOL & GREEN TEA FLAVORS)
MENTHOL (C73403 - MENTHOL)

NDC Code Structure

  • 64525 - Quality Home Products
    • 64525-0547 - Premier Value Day Time Severe Cold And Cough

NDC 64525-0547-6

Package Description: 6 GRANULE, FOR SOLUTION in 1 BOX

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

NDC Product Information

Premier Value Day Time Severe Cold And Cough Berry Infused With Menthol And Green Tea Flavors with NDC 64525-0547 is a product labeled by Quality Home Products. The generic name of Premier Value Day Time Severe Cold And Cough Berry Infused With Menthol And Green Tea Flavors is . The product's dosage form is and is administered via form.

Labeler Name: Quality Home Products

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.

  • ACESULFAME (UNII: MA3UYZ6K1H)
  • ASPARTAME (UNII: Z0H242BBR1)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • SUCROSE (UNII: C151H8M554)

Product Labeler Information

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

Labeler Name: Quality Home Products
Labeler Code: 64525
Start Marketing Date: 10-31-2009 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: 12-31-2018 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 - INACTIVATED, the listing data was inactivated by the FDA. 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]
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.

Premier Value Day Time Severe Cold And Cough Berry Infused With Menthol And Green Tea Flavors Product Label Images

Premier Value Day Time Severe Cold And Cough Berry Infused With Menthol And Green Tea Flavors 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

Otc - Active Ingredient

Active ingredients (in each packet)                        PurposeAcetaminophen 650 mg .........................Pain reliever-Fever reducerDextromethorphan hydrobromide 20 mg ..............Cough suppresantPhenylephrine hydrochloride 10 mg...................Nasal decongestant

Otc - Purpose

Uses-Temporarily relieves:    -minor aches and pains   -headache   -minor sore throat pain    -nasal and sinus congestion   -cough due to minor throat and bronchial irritation-Temporarily reduces fever

Warnings

WarningsLiver warning: This product contains acetaminophen. Severe liver damage may occur if you take-more than 6 packets in 24 hours-with other drugs containing acetaminophen-3 or more alcoholic drinks every day while using this productSore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followedby fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Otc - Ask Doctor

Ask a doctor before us if you have-liver disease    -heart disease   -high blood pressure-thyroid disease   -diabetes   -trouble urinating due to an enlarged prostate gland-cough that occurs with too much phlegm (mucus)-cough that lasts or is chronic such as occurs with smoking, asthma or emphysema.As a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Otc - Do Not Use

When using this product-do not exceed recommended dosageStop use and ask a doctor if-nervousness, dizziness, or sleeplessness occurs   -fever gets worse or lasts more than 3 days-redness or swelling is present-new symptoms occur-symptoms do not get better or worsen-pain, cough or nasal congestion gets worse or lasts more than 7 days-cough comes back or occurs with fever, rash or headache that lasts.These could be signs of a serious condition

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of childrenIn care 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.

Dosage & Administration

Directions-do not use more than directed-take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor-adults and children 12 years of age and over; dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.-children under 12 years of age: consult a doctor-if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.

Information For Patients

Other information-each packet contains:potassium 8 mg, sodium 20 mg-phenylketonurics: contains phenylalanine 14 mg per packet -store at controlled room temperature 20-25C (68-77F). Protect from excessive heat and moisture.

* Please review the disclaimer below.