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NDC 63824-0501-66 Mucinex Nightshift 650; 20; 10; 2.5 mg/20mL; mg/20mL; mg/20mL; mg/20mL Details
Mucinex Nightshift 650; 20; 10; 2.5 mg/20mL; 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; PHENYLEPHRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE.
Product Information
NDC | 63824-0501 |
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Product ID | 63824-501_7d344b25-c20a-46cf-a16d-22f9be30bc4a |
Associated GPIs | 43995904222020 |
GCN Sequence Number | 080843 |
GCN Sequence Number Description | triprolid/phenyleph/DM/acetam LIQUID 5-325MG/10 ORAL |
HIC3 | B3P |
HIC3 Description | NON-OPIOID ANTITUS-1STGEN ANTIHIST-DECON-ANALGESIC |
GCN | 47825 |
HICL Sequence Number | 046408 |
HICL Sequence Number Description | TRIPROLIDINE HCL/PHENYLEPHRINE/DEXTROMETHORPHN/ACETAMINOPHEN |
Brand/Generic | Brand |
Proprietary Name | Mucinex Nightshift |
Proprietary Name Suffix | Cold and Flu Clear and Cool |
Non-Proprietary Name | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, and TRIPROLIDINE HYDROCHLORIDE |
Product Type | HUMAN OTC DRUG |
Dosage Form | SOLUTION |
Route | ORAL |
Active Ingredient Strength | 650; 20; 10; 2.5 |
Active Ingredient Units | mg/20mL; mg/20mL; mg/20mL; mg/20mL |
Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE |
Labeler Name | RB Health (US) LLC |
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 63824-0501-66 (63824050166)
NDC Package Code | 63824-501-66 |
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Billing NDC | 63824050166 |
Package | 180 mL in 1 BOTTLE (63824-501-66) |
Marketing Start Date | 2019-06-15 |
NDC Exclude Flag | N |
Pricing Information | |
Price Per Unit | 0.05845 |
Pricing Unit | ML |
Effective Date | 2024-02-21 |
NDC Description | MUCINEX NIGHTSHFT COLD-FLU CLR |
Pharmacy Type Indicator | C/I |
OTC | Y |
Explanation Code | 1, 5, 6 |
Classification for Rate Setting | B |
As of Date | 2024-02-21 |
Standard Product Labeling (SPL)/Prescribing Information SPL 1bfacd95-3300-46a3-8699-1dcca035b6df Details
SPL UNCLASSIFIED SECTION
Uses
- temporarily relieves these common cold and flu symptoms:
- cough
- nasal congestion
- minor aches and pains
- sore throat
- headache
- runny nose
- sneezing
- sinus congestion and pressure
- itching of the nose or throat
- itchy, watery eyes due to hay fever
- temporarily reduces fever
- controls cough to help you get to sleep
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
- heart disease
- diabetes
- high blood pressure
- thyroid 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
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, nasal decongestion, or cough 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
- cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
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 over: 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
NDC 63824-501-66
Mucinex®
NIGHTSHIFT
COLD & FLU
CLEAR&COOL
Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Phenylephrine HCl – Nasal Decongestant
Triprolidine HCl – Antihistamine
NIGHT TIME
RELIEF FOR A BETTER
MORNING
✓COUGH ✓FEVER ✓SORE THROAT
✓RUNNY NOSE ✓SNEEZING ✓NASAL CONGESTION
6 FL OZ (180 mL)
FOR AGES 12+

INGREDIENTS AND APPEARANCE
MUCINEX NIGHTSHIFT
COLD AND FLU CLEAR AND COOL
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and triprolidine hydrochloride solution |
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Labeler - RB Health (US) LLC (081049410) |