EFFERVESCENT ORANGE COLD RELIEF- aspirin, chlorpheniramine maleate, phenylephrine bitartrate tablet, effervescent

Effervescent Orange Cold Relief by

Drug Labeling and Warnings

Effervescent Orange Cold Relief by is a Otc medication manufactured, distributed, or labeled by DOLGENCORP, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Aspirin 325 mg (NSAID)*

Chlorpheniramine maleate 2 mg

Phenylephrine Bitartrate 7.8 mg

*Nonsteroidal anti-inflammatory drug

Purpose

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

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

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

■ 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

■ 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 ■ if you are taking sedatives or tranquilizers

You have ■ glaucoma ■ diabetes ■ thyroid disease ■ trouble urinating due to an enlarged prostate gland ■ 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

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

When using this product

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

■ 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,

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

Keep out of reach of children.

In case of overdose,

get medical help or contact a Poison Control Center right away.

Directions

■ 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

each tablet contains:
sodium 464 mg

■ phenylketonurics: contains phenylalanine 9 mg per tablet

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

Inactive ingredients

acesulfame potassium, aspartame, citric acid, docusate sodium, FD&C red #40, FD&C yellow #6, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EFFERVESCENT ORANGE COLD RELIEF 
aspirin, chlorpheniramine maleate, phenylephrine bitartrate tablet, effervescent

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-769
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE BITARTRATE	7.8 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ASPARTAME (UNII: Z0H242BBR1)
DOCUSATE SODIUM (UNII: F05Q2T2JA0)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MANNITOL (UNII: 3OWL53L36A)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	25mm
Flavor	ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-769-20	20 in 1 CARTON	09/15/2015
1		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/15/2015

Labeler - DOLGENCORP, LLC (068331990)