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NDC 63824-0503-69 Mucinex Nightshift 650; 20; 2.5 mg/20mL; mg/20mL; mg/20mL Details
Mucinex Nightshift 650; 20; 2.5 mg/20mL; mg/20mL; mg/20mL
Mucinex Nightshift is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by RB Health (US) LLC. The primary component is ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; TRIPROLIDINE HYDROCHLORIDE.
Product Information
NDC | 63824-0503 |
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Product ID | 63824-503_e9071387-8850-436c-badc-a087a899e0ac |
Associated GPIs | 43998903302020 |
GCN Sequence Number | 080838 |
GCN Sequence Number Description | triprolidine/DM/acetaminophen LIQUID 2.5-650/20 ORAL |
HIC3 | B4G |
HIC3 Description | NON-OPIOID ANTITUS-1ST GEN ANTIHIST-ANALGESIC COMB |
GCN | 47819 |
HICL Sequence Number | 046405 |
HICL Sequence Number Description | TRIPROLIDINE HCL/DEXTROMETHORPHAN HBR/ACETAMINOPHEN |
Brand/Generic | Brand |
Proprietary Name | Mucinex Nightshift |
Proprietary Name Suffix | Cold and Flu |
Non-Proprietary Name | Acetaminophen, Dextromethorphan Hydrobromide, and Triprolidine Hydrochloride |
Product Type | HUMAN OTC DRUG |
Dosage Form | SOLUTION |
Route | ORAL |
Active Ingredient Strength | 650; 20; 2.5 |
Active Ingredient Units | mg/20mL; mg/20mL; mg/20mL |
Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; TRIPROLIDINE HYDROCHLORIDE |
Labeler Name | RB Health (US) LLC |
Pharmaceutical Class | Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA] |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH FINAL |
Application Number | part341 |
Listing Certified Through | 2024-12-31 |
Package
Package Images

NDC 63824-0503-69 (63824050369)
NDC Package Code | 63824-503-69 |
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Billing NDC | 63824050369 |
Package | 266 mL in 1 BOTTLE (63824-503-69) |
Marketing Start Date | 2019-06-15 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL a51b6312-598e-4a25-a873-6b59bc87d900 Details
SPL UNCLASSIFIED SECTION
Uses
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4000 mg in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
Allergy alert
Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
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
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- 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 taking this product.
Ask a doctor before use if you have
- liver disease
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- 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
- use caution when driving a motor vehicle or operating machinery
Directions
- do not take more than directed (see Overdose warning)
- do not take more than 4 doses in any 24-hour period
- measure only with dosing cup provided
- do not use dosing cup with other products
- dose as follows or as directed by a doctor
- adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours
- children under 12 years of age: do not use
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label
INGREDIENTS AND APPEARANCE
MUCINEX NIGHTSHIFT
COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, and triprolidine hydrochloride solution |
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Labeler - RB Health (US) LLC (081049410) |
Revised: 1/2022
Document Id: e9071387-8850-436c-badc-a087a899e0ac
Set id: a51b6312-598e-4a25-a873-6b59bc87d900
Version: 2
Effective Time: 20220107