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NDC 59779-0693-08 NightTime Cold and Flu 650; 25; 10 mg/30mL; mg/30mL; mg/30mL Details
NightTime Cold and Flu 650; 25; 10 mg/30mL; mg/30mL; mg/30mL
NightTime Cold and Flu is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Pharmacy. 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: 59779-0693-08Last Updated: 12/01/2022
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: 59779-0693-08Last 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: 59779-0693-08Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 59779-0693 |
|---|---|
| Product ID | 59779-693_1c8263a3-b601-471c-b580-f8d5c295ad9b |
| Associated GPIs | 43994003900930 |
| GCN Sequence Number | 063195 |
| GCN Sequence Number Description | diphenhyd/phenyleph/acetaminop LIQUID 25-650/30 ORAL |
| HIC3 | B3O |
| HIC3 Description | 1ST GEN ANTIHISTAMINE-DECONGESTANT-ANALGESIC COMB |
| GCN | 98952 |
| HICL Sequence Number | 035433 |
| HICL Sequence Number Description | DIPHENHYDRAMINE HCL/PHENYLEPHRINE HCL/ACETAMINOPHEN |
| Brand/Generic | Generic |
| Proprietary Name | NightTime Cold and Flu |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetaminophen, Diphenhydramine HCi, Phenylephrine HCi |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 650; 25; 10 |
| Active Ingredient Units | mg/30mL; mg/30mL; mg/30mL |
| Substance Name | ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | CVS Pharmacy |
| 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 59779-0693-08 (59779069308)
| NDC Package Code | 59779-693-08 |
|---|---|
| Billing NDC | 59779069308 |
| Package | 245 mL in 1 BOTTLE, PLASTIC (59779-693-08) |
| Marketing Start Date | 2022-06-03 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL e2fe7302-4b36-4f8b-870e-513c2382ee2d Details
Active ingredients (in each 30 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:
- skin reddening
- blisters
- rash
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
- to make a child sleepy
- 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.
- with any other product containing diphenhydramine, even one used on skin
- with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if you have
- liver disease
- glaucoma
- heart disease
- thyroid disease
- high blood pressure
- diabetes
- cough that occurs with too much phlegm (mucus)
- 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
Ask a doctor or pharmacist before use if you are taking
- the blood thinning drug warfarin
- sedatives or tranquilizers
When using this product
- do not exceed recommended dosage
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcohol 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
- 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.
Overdose warning: Taking more than the recommended dose (overdose) may 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
- do not take more than directed (see overdose warning)
- do not take more than 6 doses (180 mL) in any 24-hour period
- 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
- 30 mL every 4 hours
- children under 12 years of age; do not use
Other information
Inactive ingredients
Principal Display Panel
Compare to the active ingredients in Theraflu® ExpressMax® Nighttime Severe Cold & Cough*
Severe Cold & Cough relief
ACETAMINOPHEN
Pain reliever; Fever reducer
DIPHENHYDRAMINE HCl
Antihistamine; Cough Suppressant
PHENYLEPHRINE HCl
Nasal decongestant
Relief of:
Nasal congestion; Runny nose; Cough; Fever; Body ache; Sore throat; Headache
NIGHTTIME
Berry Flavor
Alcohol content 10%
For Ages 12 & Over
FL OZ (mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.
*This product is not manufactured or distributed by GSK Consumer Health, distributor Theraflu® ExpressMax® Nighttime Severe Cold & Cough.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
INGREDIENTS AND APPEARANCE
| NIGHTTIME COLD AND FLU
acetaminophen, diphenhydramine hci, phenylephrine hci liquid |
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| Labeler - CVS Pharmacy (062312574) |