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NDC 59779-0686-16 DayTime NightTime Cold/Flu Details
DayTime NightTime Cold/Flu
DayTime NightTime Cold/Flu is a KIT in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Pharmacy. 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: 59779-0686-16Last Updated: 12/01/2022
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: 59779-0686-16Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan
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: 59779-0686-16Last Updated: 12/01/2022
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: 59779-0686-16Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 59779-0686 |
|---|---|
| Product ID | 59779-686_bac7993a-d971-4192-a9f9-61fd744c178f |
| Associated GPIs | 4399590417C420 |
| GCN Sequence Number | 080729 |
| GCN Sequence Number Description | DM/PE/acetaminoph/diphenhydram LIQUID SEQ 10-650/30 ORAL |
| HIC3 | B3P |
| HIC3 Description | NON-OPIOID ANTITUS-1STGEN ANTIHIST-DECON-ANALGESIC |
| GCN | 47691 |
| HICL Sequence Number | 033218 |
| HICL Sequence Number Description | DEXTROMETHORPHAN/PHENYLEPHRINE/ACETAMINOPHEN/DIPHENHYDRAMINE |
| Brand/Generic | Generic |
| Proprietary Name | DayTime NightTime Cold/Flu |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Diphenhydramine HCi |
| 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 | CVS Pharmacy |
| 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 59779-0686-16 (59779068616)
| NDC Package Code | 59779-686-16 |
|---|---|
| Billing NDC | 59779068616 |
| Package | 1 KIT in 1 KIT (59779-686-16) * 245 mL in 1 BOTTLE, PLASTIC (59779-691-08) * 245 mL in 1 BOTTLE, PLASTIC (59779-693-08) |
| Marketing Start Date | 2016-07-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 9509fec8-8056-435b-8687-f01648af49a1 Details
Active ingredients in Daytime (in each 30 mL)
Active ingredients in Nighttime (in each 30 mL)
Purpose for Nighttime
Uses
- temporarily relieves these symptoms due to a cold
- minor aches and pains
- headache
- nasal and sinus congestion
- sore throat
- cough due to minor throat and bronchial irritation
- temporarily reduces fever
NIGHTTIME
- temporarily relieves these symptoms due to a cold
- minor aches and pains
- headache
- sore throat
- runny nose
- sneezing
- itchy, watery eyes due to hay fever
- nasal and sinus congestion
- itchy of the nose or throat
- cough due to minor throat and bronchial irritation
- temporarily reduces fever
Warnings
DAYTIME and NIGHTTIME
Liver warning: These products contain 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
DAYTIME
- 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, ot 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.
NIGHTTIME
- to make a child sleepy
- 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 the 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.
Ask a doctor before use if you have
DAYTIME
- liver disease
- heart disease
- thyroid disease
- diabetes
- high blood pressure
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
NIGHTTIME
- liver disease
- glaucoma
- high blood pressure
- heart disease
- diabetes
- thyroid disease
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Ask a doctor or pharmacist before use if you are
DAYTIME
taking the blood thinning drug warfarin
NIGHTTIME
- the blood thinning drug warfarin
- sedative or tranquilizers
When using this product,
DAYTIME
do not exceed recommended dosage.
NIGHTTIME
- do not exceed recommended dosage
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
- marked drowsiness may occur
- excitability may occur, especially in children
Stop use and ask a doctor if
DAYTIME
- nervousness, dizziness or sleeplessness occur
- pain, cough,or nasal congestion 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.
NIGHTTIME
- nervousness, dizziness, or sleeplessness occur
- pain, cough, or nasal congestion gets worse or lasts more than 7 days
- new symptoms occur
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- 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.
DAYTIME and NIGHTTIME
Overdose warning: Taking more than the recommended dose can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
DAYTIME and NIGHTTIME
- do not take more than directed (see Overdose warning)
- do not take more than 6 doses (180 mL) in any 24-hour peroid
- measure only with dosing cup provided. Do not use any other dosing device.
- mL = milliliter
- keep dosing cup with product
- adults and children 12 years and over:
- children under 12 years: do not use
Other information
Inactive ingredients
DAYTIME
acesulfame potassium, alcohol, citric acid, disodium EDTA, FD&C blue #1, FD&C red #40, flavor, glycerin, maltitol, propylene glycol, purified water, sodium benzoate, sodium citrate
NIGHTTIME
acesulfame potassium, alcohol, citric acid, disodium EDTA, FD&C blue #1, FD&C red #40, flavor, glycerin, maltitol, propylene glycol, purified water, sodium benzoate, sodium citrate
Principal Display Panel
DAYTIME & NIGHTTIME
Compare to the active ingredients in Theraflu® ExpressMax® Daytime & Nighttime Severe Cold & Cough*
Daytime
Severe Cold & Cough
ACETAMINOPHEN
Pain reliever; fever reducer
DEXTROMETHORPHAN HBr
Cough suppressant
PHENYLEPHRINE HCI
Nasal decongestant
Relief of:
Nasal congestion; Cough; Fever; Body ache; Sore Throat; Headache
Berry Flavor
Alcohol content 10%
For Ages 12 & Over
Nighttime
Severe Cold & Cough
ACETAMINOPHEN
Pain reliever; Fever reducer
DIPHENHYDRAMINE HCI
Anthihistamine; Cough suppressant
PHENYLEPHRINE HCI
Nasal decongestant
Relief of:
Nasal congestion; Cough; Fever; Body ache; Sore throat; Headache
Dosing Cup Included
Berry Flavor
Alcohol content 10%
for Ages 12 & Over
FL OZ (mL)
*This product is not manufactured or distributed by GSK Comsumer Healthcare, distributor of Theraflu® ExpressMax® Daytime & Nighttime Severe Cold & Cough.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
CVS.com® 1-800-SHOP CVS
INGREDIENTS AND APPEARANCE
| DAYTIME NIGHTTIME COLD/FLU
acetaminophen, dextromethorphan hbr, phenylephrine hcl, diphenhydramine hci kit |
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| Labeler - CVS Pharmacy (062312574) |