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
- Active ingredients (in each 30 mL)
- Purpose
- Uses
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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
- Directions
- Other information
- Inactive ingredients
- Questions or Comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TOPCARE NIGHTTIME COLD AND FLU SIMPLE RELIEF
choline salicylate, diphenhydramine hydrochloride, phenylephrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-888 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHOLINE SALICYLATE (UNII: KD510K1IQW) (SALICYLIC ACID - UNII:O414PZ4LPZ) CHOLINE SALICYLATE 870 mg in 1 mL DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg in 1 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-888-08 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/06/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 09/06/2016 Labeler - TOPCO ASSOCIATES LLC (006935977)