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NDC 70868-0740-16 Miclara DM 20; 10; 2.5 mg/5mL; mg/5mL; mg/5mL Details
Miclara DM 20; 10; 2.5 mg/5mL; mg/5mL; mg/5mL
Miclara DM is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Key Therapeutics. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE.
Product Information
NDC | 70868-0740 |
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Product ID | 70868-740_d67cf0cc-7c79-8640-e053-2995a90a7b1e |
Associated GPIs | 43995803960920 |
GCN Sequence Number | 072192 |
GCN Sequence Number Description | triprolidine/phenylephrine/DM LIQUID 2.5-10-20 ORAL |
HIC3 | B3R |
HIC3 Description | NON-OPIOID ANTITUS-1ST GEN.ANTIHISTAMINE-DECONGEST |
GCN | 36311 |
HICL Sequence Number | 041030 |
HICL Sequence Number Description | TRIPROLIDINE HCL/PHENYLEPHRINE HCL/DEXTROMETHORPHAN HBR |
Brand/Generic | Brand |
Proprietary Name | Miclara DM |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Dextromethorphan HBr, Phenylephrine HCl, Triprolidine HCl |
Product Type | HUMAN OTC DRUG |
Dosage Form | LIQUID |
Route | ORAL |
Active Ingredient Strength | 20; 10; 2.5 |
Active Ingredient Units | mg/5mL; mg/5mL; mg/5mL |
Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE |
Labeler Name | Key Therapeutics |
Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH FINAL |
Application Number | part341 |
Listing Certified Through | 2023-12-31 |
Package
Package Images

NDC 70868-0740-16 (70868074016)
NDC Package Code | 70868-740-16 |
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Billing NDC | 70868074016 |
Package | 473 mL in 1 BOTTLE (70868-740-16) |
Marketing Start Date | 2020-09-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL c86e012b-17d0-4ffd-b815-9c07771bfaf1 Details
Active ingredients
Uses
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.
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 |
Inactive ingredients
Questions? Comments?
INGREDIENTS AND APPEARANCE
MICLARA DM
dextromethorphan hbr, phenylephrine hcl, triprolidine hcl liquid |
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Labeler - Key Therapeutics (080318791) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
TG United | 172837085 | manufacture(70868-740) |
Revised: 1/2022
Document Id: d67cf0cc-7c79-8640-e053-2995a90a7b1e
Set id: c86e012b-17d0-4ffd-b815-9c07771bfaf1
Version: 3
Effective Time: 20220126