Label: MICLARA DM- dextromethorphan hbr, phenylephrine hcl, triprolidine hcl liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 70868-740-16 - Packager: Key Therapeutics
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 26, 2022
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- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Uses
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Warnings
Do not exceed recommended dosage.
Do not use this product
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 giving this product.
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
- heart disease
- high blood pressure
- a cough that occurs with too much phlegm (mucus)
- a persistent chronic cough such occurs with smoking, asthma, chronic bronchitis, or emphysema
When using this product
- excitability may occur, especially in children
- may cause drowsiness
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- new symptoms occur
- nervousness, dizziness, or sleeplessness occur
- Cough or nasal congestion lasts for more than 1 week, tends to recur or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
- a breathing problem such as emphysema or chronic bronchitis
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Directions
Do not exceed recommended dosage.
Age Dose Adults and children 12 years of age and older: 1 teaspoonful (5mL) every 4 hours, not to exceed 4 teaspoonfuls (20mL) in a 24-hour period or as directed by a doctor Children 6 to under 12 years of age: ½ teaspoonful (2.5mL) every 4 hours, not to exceed 2 teaspoonfuls (10mL) in a 24-hour period or as directed by a doctor Children under 6 years of age: Consult a doctor - Other information
- Inactive ingredients
- Questions? Comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MICLARA DM
dextromethorphan hbr, phenylephrine hcl, triprolidine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70868-740 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 5 mL TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE 2.5 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) METHYLPARABEN (UNII: A2I8C7HI9T) POTASSIUM CITRATE (UNII: EE90ONI6FF) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color Score Shape Size Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70868-740-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 09/01/2020 Labeler - Key Therapeutics (080318791) Establishment Name Address ID/FEI Business Operations TG United 172837085 manufacture(70868-740)