GOOD NEIGHBOR PHARMACY SINUS AND COLD D- naproxen sodium, pseudoephedrine hcl tablet, film coated, extended release

United States - English - NLM (National Library of Medicine)

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Active ingredient:
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ), PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)
Available from:
Amerisource Bergen
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer Nasal decongestant temporarily relieves these cold, sinus, and flu symptoms:
Authorization status:
Abbreviated New Drug Application
Authorization number:
46122-197-52

GOOD NEIGHBOR PHARMACY SINUS AND COLD D- naproxen sodium, pseudoephedrine

hcl tablet, film coated, extended release

Amerisource Bergen

----------

Amerisource Bergen Sinus & Cold-D Drug Facts

Active ingredients (in each caplet)

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

Pseudoephedrine HCl 120 mg, extended-release

*nonsteroidal anti-inflammatory drug

Purpos es

Pain reliever/fever reducer

Nasal decongestant

Us es

temporarily relieves these cold, sinus, and flu symptoms:

Warnings

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

aspirin. Symptoms may include:

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:

sinus pressure

minor body aches and pains

headache

nasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose)

fever

hives

facial swelling

asthma (wheezing)

shock

skin reddening

rash

blisters

are age 60 or older

have had stomach ulcers or bleeding problems

take a blood thinning (anticoagulant) or steroid drug

Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart

failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer

than directed.

Do not use

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

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

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

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, kidney disease, asthma, thyroid

disease, diabetes, have trouble urinating due to an enlarged prostate gland, or had a stroke

you are taking a diuretic

you have problems or serious side effects from taking pain relievers or fever reducers

under a doctor’s care for any serious condition

taking any other drug

take with food or milk if stomach upset occurs

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

you have symptoms of heart problems or stroke:

chest pain

trouble breathing

weakness in one part or side of body

slurred speech

leg swelling

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

Other information

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

See New Warnings

Non-Drowsy

Sinus & Cold-D

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

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

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

each caplet contains: sodium 21 mg

meets USP Dissolution Test 2

store at 20-25°C (68-77°F)

store in a dry place

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 – 12 Hours

actual size

10 Caplets**

(**Capsule-shaped tablets)

GOOD NEIGHBOR PHARMACY SINUS AND COLD D

naproxen sodium, pseudoephedrine hcl tablet, film coated, extended release

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:46 122-19 7

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

NAPRO XEN SO DIUM (UNII: 9 TN8 7S3A3C) (NAPROXEN - UNII:57Y76 R9 ATQ)

NAPROXEN SODIUM

220 mg

PSEUDO EPHEDRINE HYDRO CHLO RIDE (UNII: 6 V9 V2RYJ8 N) (PSEUDOEPHEDRINE

- UNII:7CUC9 DDI9 F)

PSEUDOEPHEDRINE

HYDROCHLORIDE

120 mg

Inactive Ingredients

Ingredient Name

Stre ng th

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

PO LYETHYLENE GLYCO L (UNII: 3WJQ0 SDW1A)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

OVAL

S iz e

18 mm

Flavor

Imprint Code

L417

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:46 122-19 7-52

10 in 1 CARTON

0 8 /22/20 13

1

1 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Amerisource Bergen

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 76 518

0 8 /22/20 13

Labeler -

Amerisource Bergen (007914906)

Revised: 2/2019

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