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NDC 30142-0949-30 night time cold and flu 650; 25; 10 mg/20mL; mg/20mL; mg/20mL Details
night time cold and flu 650; 25; 10 mg/20mL; mg/20mL; mg/20mL
night time cold and flu is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Kroger Company. The primary component is ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
Related Packages: 30142-0949-30Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen
Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
Related Packages: 30142-0949-30Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
Related Packages: 30142-0949-30Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 30142-0949 |
|---|---|
| Product ID | 30142-949_44efc825-c892-4a79-9f32-a2beaf5d2316 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | night time cold and flu |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 650; 25; 10 |
| Active Ingredient Units | mg/20mL; mg/20mL; mg/20mL |
| Substance Name | ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | Kroger Company |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 30142-0949-30 (30142094930)
| NDC Package Code | 30142-949-30 |
|---|---|
| Billing NDC | 30142094930 |
| Package | 180 mL in 1 BOTTLE (30142-949-30) |
| Marketing Start Date | 2019-05-22 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 30663e89-df52-4607-b77e-6bbf3934330c Details
Active ingredients (in each 20 mL)
Uses
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- •
- more than 4,000 mg of acetaminophen in 24 hours
- •
- with other drugs containing acetaminophen
- •
- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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- skin reddening
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- 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.
- •
- with any other product containing diphenhydramine, even one used on skin
- •
- 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.
- •
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
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- 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
When using this product
Stop use and ask a doctor if
- •
- nervousness, dizziness or sleeplessness occur
- •
- pain, nasal congestion, 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 rash or headache that lasts. These could be signs of a serious condition.
Keep out of reach of children.
Directions
- •
- do not take more than directed (see Overdose warning)
- •
- do not take more than 5 doses in any 24-hour period
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- measure only with dosing cup provided
- •
- do not use dosing cup with other products
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- dose as follows or as directed by a doctor
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- 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
Other information
Inactive ingredients
Package/Label Principal Display Panel
COMPARE TO the active ingredients of MUCINEX® FAST-MAX® NIGHT TIME COLD & FLU
See back panel
for ages 12+
OUR PHARMACIST RECOMMENDED
Maximum Strength
FAST NIGHTTIME
Cold & Flu
Acetaminophen
Pain Reliever/Fever Reducer
Diphenhydramine HCl
Antihistamine/Cough Suppressant
Phenylephrine HCl
Nasal Decongestant
1 FOR ALL RELIEF
NASAL CONGESTION
SNEEZING, RUNNY NOSE
ACHES, HEADACHE
COUGH, ITCHY THROAT
6 FL OZ (180 mL)
INGREDIENTS AND APPEARANCE
| NIGHT TIME COLD AND FLU
acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride solution |
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| Labeler - Kroger Company (006999528) |