Effervescent Cold Relief

Manufacturer
Amerisource Bergen Corporation (Good Neighbor Pharmacy)
Effective date
2020-11-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:05:52

Label at a glance#

ProductEffervescent Cold Relief
Active ingredientPHENYLEPHRINE BITARTRATE, CHLORPHENIRAMINE MALEATE, ASPIRIN
Label structure16 sections

Indications and uses

temporarily relieves these symptoms of the common cold: ■ fever ■ sneezing ■ nasal congestion ■ sore throat ■ headache ■ minor aches and pains ■ runny nose ■ sinus congestion and pressure

Dosage and administration

■ do not use more than directed (see overdose warning) ■ adults and children 12 years and over: take 2 tablets completely dissolved in 4 ounces of water every 4-6 hours ■ do not take more than 8 tablets in 24 hours ■ children under 12 years: ask a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Aspirin 325 mg NSAID*

Chlorpheniramine maleate 2 mg

Phenylephrine bitartrate 7.8 mg

*Nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Aspirin 325 mg NSAID*. . . . . . . . . . . . . . . . . . .Pain reliever/fever reducer

Chlorpheniramine maleate 2 mg . . . . . . . . . . . ..Antihistamine

Phenylephrine bitartrate 7.8 mg . . . . . . . . . . . . .Nasal decongestant

*Nonsteroidal anti-inflammatory drug

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms of the common cold:

■ fever ■ sneezing ■ nasal congestion ■ sore throat ■ headache

■ minor aches and pains ■ runny nose

■ sinus congestion and pressure

Warnings

WARNINGS SECTION

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction which may include: ■ hives ■ facial swelling ■ asthma (wheezing) ■ shock

Stomach bleeding warning: This product contains a non-steroidal anti-inflammatory drug (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 non-prescription 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

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

OTC - DO NOT USE SECTION

■ if you have ever had an allergic reaction to any other pain reliever/fever reducer

■ if you are allergic to aspirin ■ 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.

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

■ 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 ■ glaucoma ■ diabetes ■ thyroid disease ■ trouble urinating due to an enlarged prostate glad ■ a breathing problem such as emphysema or chronic bronchitis ■ been placed on a sodium-restricted diet.

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

■ presently taking a prescription drug ■ taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout or arthritis

When using this product

OTC - WHEN USING SECTION

■ do not take more than 8 tablets (adults and children 12 years and over) in a 24-hour period or as directed by a doctor.

■ do not use more than directed

■ you may get drowsy

■ avoid alcoholic drinks

■ excitability may occur, especially in children

■ alcohol, sedatives and tranquilizers may increase drowsiness

■ be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ 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

■ an allergic reaction occurs. Seek medical help right away.

■ pain or nasal congestion gets worse or lasts more than 7 days

■ fever gets worse or lasts more than 3 days

■ new symptoms occur

■ redness or swelling is present

■ ringing in the ears or a loss of hearing occurs

■ nervousness, dizziness or sleeplessness occurs

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use. It is especially important not to use aspirin 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

■ do not use more than directed (see overdose warning)

■ adults and children 12 years and over: take 2 tablets completely dissolved in 4 ounces of water every 4-6 hours

■ do not take more than 8 tablets in 24 hours

■ children under 12 years: ask a doctor

Other information

OTHER SAFETY INFORMATION

each tablet contains:
sodium 464 mg

■ phenylketonurics: contains phenylalanine 9 mg per tablet

■ store at room temperature (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, aspartame, citric acid, docusate sodium, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate

Package Label.Principle Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Good Neighbor Cold 20Good Neighbor Cold 20

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
46122-06346122-063-60

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b4c9e6fd-af06-e3f6-e053-2a95a90ac87768a6518f-8143-2bcd-e053-2a91aa0a22562020-11-23WarningsExact identifier
spl id: b4c9e6fd-af06-e3f6-e053-2a95a90ac877
spl set id: 68a6518f-8143-2bcd-e053-2a91aa0a2256

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.