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NDC 30142-0051-90 DayTime NiteTime Severe Details
DayTime NiteTime Severe
DayTime NiteTime Severe is a KIT in the HUMAN OTC DRUG category. It is labeled and distributed by Kroger Company. The primary component is .
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: 30142-0051-90Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
Related Packages: 30142-0051-90Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan
Doxylamine is used in the short-term treatment of insomnia (difficulty falling asleep or staying asleep). Doxylamine is also used in combination with decongestants and other medications to relieve sneezing, runny nose, and nasal congestion caused by the common cold. Doxylamine should not be used to cause sleepiness in children. Doxylamine 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: 30142-0051-90Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Doxylamine
Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.
Related Packages: 30142-0051-90Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin
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: 30142-0051-90Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 30142-0051 |
|---|---|
| Product ID | 30142-051_c8cbd869-e5a1-4c67-aa35-f6da0cff31e7 |
| Associated GPIs | |
| GCN Sequence Number | 077380 |
| GCN Sequence Number Description | doxylam/PE/DM/acetaminophen/GG TABLET SEQ 5-10-325MG ORAL |
| HIC3 | B4O |
| HIC3 Description | NON-OPIOID ANTITUS-1ST ANTIHIST-DECON-ANALG-EXPECT |
| GCN | 43367 |
| HICL Sequence Number | 040604 |
| HICL Sequence Number Description | DOXYLAMINE/PHENYLEPHRINE/DEXTROMETHORPHAN/ACETAMINOPHEN/GG |
| Brand/Generic | Generic |
| Proprietary Name | DayTime NiteTime Severe |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Guaifenesin, Phenylephrine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | KIT |
| Route | n/a |
| Active Ingredient Strength | n/a |
| Active Ingredient Units | n/a |
| Substance Name | n/a |
| Labeler Name | Kroger Company |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 30142-0051-90 (30142005190)
| NDC Package Code | 30142-051-90 |
|---|---|
| Billing NDC | 30142005190 |
| Package | 24 BLISTER PACK in 1 CARTON (30142-051-90) / 1 KIT in 1 BLISTER PACK * 16 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED in 1 BLISTER PACK * 8 BLISTER PACK in 1 CARTON / 8 TABLET, FILM COATED in 1 BLISTER PACK |
| Marketing Start Date | 2017-05-24 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL bac430ac-0db3-4218-ba9a-accf842f8e90 Details
Active ingredients (in each caplet) - Nighttime
Active ingredients (in each caplet) - Daytime
Uses - Nighttime
- •
- temporarily relieves common cold/flu symptoms:
- •
- nasal congestion
- •
- sinus congestion and pressure
- •
- cough due to minor throat and bronchial irritation
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- cough to help you sleep
- •
- minor aches and pains
- •
- headache
- •
- fever
- •
- sore throat
- •
- runny nose and sneezing
- •
- reduces swelling of nasal passages
- •
- temporarily restores freer breathing through the nose
- •
- promotes nasal and/or sinus drainage
Uses - Daytime
- •
- temporarily relieves common cold/flu symptoms:
- •
- nasal congestion
- •
- sinus congestion and pressure
- •
- cough due to minor throat and bronchial irritation
- •
- minor aches and pains
- •
- headache
- •
- fever
- •
- sore throat
- •
- reduces swelling of nasal passages
- •
- temporarily restores freer breathing through the nose
- •
- promotes nasal and/or sinus drainage
- •
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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:
- •
- 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.
- •
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have - Nighttime
- •
- liver disease
- •
- heart disease
- •
- high blood pressure
- •
- thyroid disease
- •
- diabetes
- •
- glaucoma
- •
- cough that occurs with too much phlegm (mucus)
- •
- a breathing problem such as emphysema or chronic bronchitis
- •
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- •
- trouble urinating due to an enlarged prostate gland
Ask a doctor before use if you have - Daytime
Ask a doctor or pharmacist before use if you are - Nighttime
When using this product - Nighttime
Stop use and ask a doctor if - Nighttime
- •
- you get nervous, dizzy or sleepless
- •
- 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
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- new symptoms occur
- •
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
Stop use and ask a doctor if - Daytime
- •
- you get nervous, dizzy or sleepless
- •
- 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 – Nighttime and Daytime
Inactive ingredients - Nighttime
crospovidone, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide
Inactive ingredients - Daytime
Package/Label Principal Display Panel - Daytime
COMPARE TO the active ingredients of VICKS® DAYQUIL® SEVERE
See side panel
NON-Drowsy
DayTime
Severe Cold & Flu
Acetaminophen, Phenylephrine HCl,
Dextromethorphan HBr, Guaifenesin
Pain Reliever/Fever Reducer,
Nasal Decongestant,
Cough Suppressant, Expectorant
MAXIMUM STRENGTH RELIEF
Headache, Fever, Sore Throat, Minor Aches & Pains
Nasal/Sinus Congestion & Sinus Pressure
Cough
Chest Congestion
Our Pharmacists Recommend
16 DAYTIME SEVERE CAPLETS
actual size
COMPARE TO the active ingredients of VICKS® NYQUIL® SEVERE
See side panel
NiteTime
Severe Cold & Flu
Acetaminophen, Phenylephrine HCl,
Doxylamine Succinate, Dextromethorphan HBr
Pain Reliever, Fever Reducer,
Cough Suppressant, Antihistamine
Nasal Decongestant
MAXIMUM STRENGTH RELIEF
Our Pharmacists Recommend
8 NIGHTTIME SEVERE CAPLETS
actual size
INGREDIENTS AND APPEARANCE
| DAYTIME NITETIME SEVERE
acetaminophen, dextromethorphan hbr, doxylamine succinate, guaifenesin, phenylephrine hcl kit |
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| Labeler - Kroger Company (006999528) |