NDC | 58809-372-08 |
Set ID | 17a39de8-1702-0711-e054-00144ff8d46c |
Category | HUMAN OTC DRUG LABEL |
Packager | GM Pharmaceuticals, INC |
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
■ in children under 12 years of age
■ 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.
■ if you have ever had an allergic reaction to this product or any of its ingredients
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 difficulty in urination due to enlargement of the prostate gland
■ you have a breathing problem such as emphysema or chronic bronchitis
■ you have a cough with excessive phlegm (mucus)
■ 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
■ under a doctor’s care for any serious condition
■ taking sedatives or tranquilizers
■ taking a diuretic
When using this product
■ do not use more than directed
■ marked drowsiness may occur
■ avoid alcoholic drinks
■ alcohol, sedatives, and tranquilizers may increase drowsiness
■ be careful when driving a motor vehicle or operating machinery
■ excitability may occur, especially in children
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.
- hives
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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=milliliter
adults and children
12 years of age and over:30 mL
every 4 hourschildren under 12 years of age:
Do not use.Other information
■ each 30mL contains: Sodium 15 mg
■ store at 20° to 30°C (68° to 86°F)
■ this package is child-resistant
■ read all product information before using
- do not exceed recommended dosage.
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
TEXACLEAR NIGHT TIME COUGH COLD/FLU
choline salicylate, diphenhydramine hydrochloride, phenylephrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58809-372 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 30 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 30 mL DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg in 30 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 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:58809-372-08 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/23/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 10/23/2014 Labeler - GM Pharmaceuticals, INC (793000860)