Label: TEXACLEAR DAYTIME COUGH COLD/FLU- choline salicylate, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
- NDC Code(s): 58809-391-08
- Packager: GM Pharmaceuticals, INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 27, 2023
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- 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.
- 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, or thyroid disease
- you have chronic pulmonary disease or shortness of breath
- you have difficulty in urination due to enlargement of the prostate gland
- 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 a diuretic
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
- feel faint
- Hives
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TEXACLEAR DAYTIME COUGH COLD/FLU
choline salicylate, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58809-391 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 DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 30 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 30 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 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:58809-391-08 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/21/2014 08/31/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 10/21/2014 08/31/2024 Labeler - GM Pharmaceuticals, INC (793000860) Establishment Name Address ID/FEI Business Operations MONARCH PCM LLC 080000294 manufacture(58809-391)
