EFFERVESCENT COLD RELIEF- aspirin, chlorpheniramine maleate, phylephrine bitartrate tablet, effervescent 
Topco Associates LLC

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.

----------

TopCare Effervescent Cold Relief

Active ingredients

Active ingredients

(in each effervescent tablet) . . . . . . . . . . .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

Purpose

(in each effervescent tablet) . . . . . . . . . . . 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 due to the common cold

■ sneezing ■ nasal congestion ■ sore throat

■ headache ■ minor aches and pains ■ runny nose

■ sinus congestion and pressure

■ temporarily reduces fever

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 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

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

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. ■ if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if

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

Ask a doctor before use if you have

Ask a doctor before use if you have ■ asthma ■ 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

Ask a doctor or pharmacist before use if you are ■ you are taking sedatives or tranquilizers ■ presently taking a prescription drug

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

When using this product

When using this product do not exceed recommended dosage

■ 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

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 breast-feeding

If pregnant or breast-feeding, 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

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 oz of water every 4 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, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate

Questions or Comments?

Call 1-888-423-0139

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Top Care Cold 20

EFFERVESCENT COLD RELIEF 
aspirin, chlorpheniramine maleate, phylephrine bitartrate tablet, effervescent
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-768
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE7.8 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
Inactive Ingredients
Ingredient NameStrength
MANNITOL (UNII: 3OWL53L36A)  
POVIDONE K30 (UNII: U725QWY32X)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ASPARTAME (UNII: Z0H242BBR1)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize25mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-768-2010 in 1 CARTON07/01/2010
12 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/2010
Labeler - Topco Associates LLC (006935977)

Revised: 11/2021
Document Id: d04a5435-c302-5722-e053-2995a90a8b12
Set id: a2929bcb-fa81-4f15-b087-a9996b5e7d1f
Version: 6
Effective Time: 20211108
 
Topco Associates LLC