Good Neighbor Pharmacy Sinus and Cold D description, usages, side effects, indications, overdosage, supplying and lots more!

Good Neighbor Pharmacy Sinus and Cold D

Amerisource Bergen

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Amerisource Bergen Sinus & Cold-D Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each caplet)

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*

Pseudoephedrine HCl 120 mg, extended-release

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Nasal decongestant

Uses

temporarily relieves these cold, sinus, and flu symptoms:

  • •sinus pressure
  • •minor body aches and pains
  • •headache
  • •nasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose)
  • •fever

Warnings

Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

  • •hives
  • •facial swelling
  • •asthma (wheezing)
  • •shock
  • •skin reddening
  • •rash
  • •blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

  • •are age 60 or older
  • •have had stomach ulcers or bleeding problems
  • •take a blood thinning (anticoagulant) or steroid drug
  • •take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • •have 3 or more alcoholic drinks every day while using this product
  • •take more or for a longer time than directed

Do not use

  • •if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • •right before or after heart surgery
  • •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.
  • •in children under 12 years of age

Ask a doctor before use if

  • •the stomach bleeding warning applies to you
  • •you have a history of stomach problems, such as heartburn
  • •you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • •you are taking a diuretic
  • •you have problems or serious side effects from taking pain relievers or fever reducers
  • •you have
  • •asthma
  • •diabetes
  • •thyroid disease
  • •trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

  • •under a doctor’s care for any serious condition
  • •taking any other drug

When using this product

  • •take with food or milk if stomach upset occurs
  • •the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask a doctor if

  • •you experience any of the following signs of stomach bleeding:
  • •feel faint
  • •vomit blood
  • •have bloody or black stools
  • •have stomach pain that does not get better
  • •redness or swelling is present in the painful area
  • •any new symptoms appear
  • •fever gets worse or lasts more than 3 days
  • •you have difficulty swallowing or the caplet feels stuck in your throat
  • •you get nervous, dizzy, or sleepless
  • •nasal congestion lasts more than 7 days

If pregnant or breast-feeding

ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

  • •do not take more than directed
  • •the smallest effective dose should be used
  • •swallow whole; do not crush or chew
  • •drink a full glass of water with each dose
  • •adults and children 12 years and older: 1 caplet every 12 hours; do not take more than 2 caplets in 24 hours
  • •children under 12 years: do not use

Other information

  • •each caplet contains: sodium 22 mg
  • •store at 20-25°C (68-77°F)
  • •store in a dry place

Inactive ingredients

colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, titanium dioxide

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to Aleve-D® Sinus & Cold active ingredients

NON-DROWSY

Sinus & Cold-D

naproxen sodium 220 mg and pseudoephedrine hydrochloride 120 mg extended-release tablet

Pain Reliever/Fever Reducer (NSAID)

Nasal Decongestant

12-Hour Multi-Symptom Relief of:

Sinus Pressure

Headache

Sinus Congestion

Nasal Congestion

Body Aches

1 Caplet Every 12 Hours

10 caplets**

**capsule shaped tablets

actual size

Good Neighbor Pharmacy Sinus and Cold D

Naproxen sodium, Pseudoephedrine HCl TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:46122-197
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
naproxen sodium NAPROXEN 220 mg
Pseudoephedrine Hydrochloride Pseudoephedrine 120 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
HYPROMELLOSES
lactose monohydrate
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYETHYLENE GLYCOLS
polysorbate 80
POVIDONES
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
WHITE 17 mm L417 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 10 in 1 BLISTER PACK
2 NDC:46122-197-52 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076518 2013-08-22


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.