TOPCARE NIGHTTIME COLD AND FLU SIMPLE RELIEF (CHOLINE SALICYLATE, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]

TOPCARE NIGHTTIME COLD AND FLU SIMPLE RELIEF (CHOLINE SALICYLATE, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]
PDF | XML

NDC 36800-888-08
Set ID aa264ce6-41a0-4099-86c7-5fcdc1bb9da3
Category HUMAN OTC DRUG LABEL
Packager TOPCO ASSOCIATES LLC
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • SPL UNCLASSIFIED SECTION

    TopCare Nighttime Cold & Flu Simple Relief

    (choline salicylate, diphenhydramine hcI, phenylephrine hcl), solution

    Topco Associates LLC

    --

    Topco Associates LLC. Nighttime Cold & Flu Simple Relief

    Drug Facts

  • Active ingredients (in each 30 mL)

     

    Choline Salicylate (NSAID)* 870 mg

    Diphenhydramine HCI 50mg

    Phenylephrine HCl 10 mg

  • Purpose

    Pain reliever/fever reducer

    Antihistamine

    Nasal decongestant

    nonsteroidal anti-inflammatory drug*

  • Uses

    temporarily relieves these common cold and flu symptoms:

    ▪ nasal congestion

    ▪ minor aches and pains

    ▪ runny nose

    ▪ sneezing

    ▪ watery eyes

    ▪ sore throat

    ▪ headache

    ▪ 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

    Salicylates (NSAIDs) may cause a severe allergic reaction which may include:

    ▪ hives

    ▪ rash

    ▪ shock

    ▪ skin reddening

    ▪ facial swelling ▪ asthma (wheezing)

    Stomach bleeding warnings

    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 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 salicylates (including aspirin) or any other pain reliever / fever reducer.

    ▪ with any other drug containing diphenhydramine, even one used on the skin

    ▪ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or 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

    Ask a doctor before use if

    ▪ stomach bleeding warning applies to you

    ▪ you have a history of stomach problems, such as heartburn or if you have ulcers or bleeding problems

    ▪ you have high blood pressure, heart disease, liver cirrhosis, kidney disease, diabetes, thyroid disease, or glaucoma

    ▪ you have a cough with excessive phlegm (mucus)

    ▪ you have difficulty in urination due to enlargement of the prostate gland

    ▪ you have breathing problems such as emphysema or chronic bronchitis

    ▪ you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

    Ask a doctor or pharmacist before use if you are

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

    ▪ taking a diuretic

    ▪ under a doctor’s care for any serious condition

    ▪ taking sedatives or tranquilizers

    When using this product

    ▪ do not use more than directed

    ▪ excitability may occur, especially in children

    ▪ marked drowsiness may occur

    ▪ alcohol, sedatives, and tranquilizers may increase drowsiness

    ▪ avoid alcoholic drinks

    ▪ be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

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

    ▪ pain, cough, or nasal congestion gets worse or lasts more than 7 days

    ▪ fever gets worse or lasts more than 3 days

    ▪ redness or swelling is present

    ▪ new symptoms occur

    ▪ ringing in the ears or a loss of hearing occurs

    ▪ cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

    ▪ nervousness, dizziness, or sleeplessness 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

    If pregnant or breast-feeding,

    ask a health professional before use. It is especially important not to use salicylates (NSAIDs) 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.

  • Directions

    • do not exceed recommended dosage.
    • do not take more than 6 doses in any 24-hour period.
    • use enclosed dose cup
    • keep dosage cup with product
    • mL = milliliters
    • adults and children 12 years of age and over: 30mL every 4 hours
    • children under 12 years of age: do not use
  • Other information

    • each 30mL contains: Sodium 16 mg
    • tamper evident: Do not use if foil seal under cap is broken or missing.
    • read all product information before using
    • store at 68° to 86°F (20° to 30°C)
    • avoid excessive heat and humidity
  • Inactive ingredients

    citric acid anhydrous, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol

  • Questions or Comments?

    Call 1-888-423-0139

  • PRINCIPAL DISPLAY PANEL

    NDC 36800-888-08
    Nighttime
    Cold & Flu
    Simple Relief
    8 FL OZ (237mL)

    PRINCIPAL DISPLAY PANEL
NDC 36800-888-08
Nighttime
Cold & Flu
Simple Relief
8 FL OZ (237mL)

    PRINCIPAL DISPLAY PANEL
NDC 36800-888-08
Nighttime
Cold & Flu
Simple Relief
8 FL OZ (237mL)

    PRINCIPAL DISPLAY PANEL
NDC 36800-888-08
Nighttime
Cold & Flu
Simple Relief
8 FL OZ (237mL)

  • INGREDIENTS AND APPEARANCE
    TOPCARE NIGHTTIME COLD AND FLU SIMPLE RELIEF 
    choline salicylate, diphenhydramine hydrochloride, phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-888
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHOLINE SALICYLATE (UNII: KD510K1IQW) (SALICYLIC ACID - UNII:O414PZ4LPZ) CHOLINE SALICYLATE870 mg  in 1 mL
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg  in 1 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-888-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product09/06/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34109/06/2016
    Labeler - TOPCO ASSOCIATES LLC (006935977)

Related Drugs