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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV), CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U), ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)

Available from:

Amerisource Bergen Corporation (Good Neighbor Pharmacy)

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Aspirin 325 mg NSAID*. . . . . . . . . . . . . . . . . . .Pain reliever/fever reducer Chlorpheniramine maleate 2 mg . . . . . . . . . . . ..Antihistamine Phenylephrine bitartrate 7.8 mg . . . . . . . . . . . . .Nasal decongestant *Nonsteroidal anti-inflammatory drug 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 ■ 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. ■ stomach bleeding warning applies to you ■ you have a history of stomach problems such as heartburn ■ you have high bloo

Authorization status:

OTC monograph final

Summary of Product characteristics

EFFERVESCENT COLD RELIEF- ASPIRIN, CHLORPHENIRAMINE MALEATE,
PHENYLEPHRINE
BITARTRATE TABLET, EFFERVESCENT
AMERISOURCE BERGEN CORPORATION (GOOD NEIGHBOR PHARMACY)
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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GOOD NEIGHBOR PHARMACY EFFERVESCENT COLD RELIEF PLUS
ACTIVE INGREDIENTS
Aspirin 325 mg NSAID*
Chlorpheniramine maleate 2 mg
Phenylephrine bitartrate 7.8 mg
*Nonsteroidal anti-inflammatory drug
PURPOS E
Aspirin 325 mg NSAID*. . . . . . . . . . . . . . . . . . .Pain
reliever/fever reducer
Chlorpheniramine maleate 2 mg . . . . . . . . . . . ..Antihistamine
Phenylephrine bitartrate 7.8 mg . . . . . . . . . . . . .Nasal
decongestant
*Nonsteroidal anti-inflammatory drug
US ES
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 long