CVS Daytime and Nighttime Severe Cold and Flu Relief Bundle
- Manufacturer
- CVS Pharmacy
- Effective date
- 2022-12-23
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:42:57
Label at a glance#
ProductCVS Daytime and Nighttime Severe Cold and Flu Relief Bundle
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE
Label structure3 sections
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
CVS Daytime Severe Cold & Flu Relief
Active Ingredients (in each Single-Use Vial, 15mL)
Acetaminophen USP, 325mg
Dextromethorphan HBr, USP, 10mg
Guaifenesin, USP 200mg
Phenylephrine HCl, USP, 5mg
Purposes
Pain Reliever/ Fever reducer
Cough suppressant
Expectorant
Nasal Decongestant
Uses
Temporarily relieves common cold/flu symptoms:
■ nasal congestion ■ sinus congestion & pressure ■ cough due to minor throat & bronchial irritation ■ minor aches & 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 8 vials in 24 hours which is the maximum daily amount for this product ■ 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
Ask a doctor before use if you have
■ liver disease ■ heart disease ■ high blood pressure ■ thyroid disease
■ diabetes ■ trouble urinating due to enlarged prostate gland ■ cough that occurs with too much phlegm (mucus) ■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask a doctor or pharmacist before use if you
taking the blood thinning drug warfarin.
When using this product
do not use more than directed.
Stop use and ask a doctor if
■ 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.
If pregnant or breast-feeding
ask a health professional before use
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children
OVERDOSAGE SECTION
In case of overdose, get medical help or contact a Poison Control Center 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
■ empty each Single-Use Vial of all liquid when dosing.
■ use the chart below to confirm the dose
| Age (Years) | Dose |
| Children under 4 years old | Do not use |
| Children 4 to under 12 years old | Ask a doctor |
| Adults and children 12 years and over | 2 Single Use Vials (15 mL) Every 4 hours while symptoms last Do not exceed 8 Single Use Vials in 24 hours |
Other information
■ each single-use vial (15 mL) contains 16mg of sodium
■ Store at 20-25oC (68-77oF)
■ Tamper Evident: do not use if the clear sealing label is broken or missing. Do not use if any vial is open or broken.
Inactive Ingredients
citric acid, edetate disodium, glycerin, maltitol, mixed berry flavor, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose, trisodium citrate, xanthan gum
Question or Comments?
1-800-719-9260
SPL UNCLASSIFIED SECTION
CVS Nighttime Severe Cold & Flu Relief
Active Ingredients (in each Single-Use Vial, 30mL)
Acetaminophen USP, 650mg
Dextromethorphan HBr, USP, 20mg
Doxylamine succinate, USP, 12.5mg
Phenylephrine HCl, USP, 10mg
Purposes
Pain Reliever/ Fever reducer
Cough suppressant
Antihistamine
Nasal Decongestant
Uses
temporarily relieves common cold/flu symptoms:
■ nasal congestion ■ sinus congestion & pressure ■ cough due to minor throat & bronchial irritation ■ cough to help you sleep ■ minor aches & pains ■ headache ■ fever ■ sore throat ■ runny nose & sneezing ■ reduces swelling of nasal passages ■ temporarily restores freer breathing through the nose ■ promotes nasal and/or sinus drainage
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: ■ more than 4 vials in 24 hours which is the maximum daily amount for this product ■ 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 ■ to make a child sleep
Ask a doctor before use if you have
■ liver disease ■ heart disease ■ high blood pressure ■ thyroid disease
■ diabetes ■ glaucoma ■ cough that occurs with too much phlegm (mucus) ■ a breathing problem or persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema ■ trouble urinating due to enlarged prostate gland
Ask a doctor or pharmacist before use if you are
■ taking sedatives or tranquilizers ■ taking the blood thinning drug warfarin
When using this product
■ do not use more than directed ■ excitability may occur, especially in children ■ marked drowsiness may occur ■ avoid alcoholic drinks ■ be careful when driving a motor vehicle or operating machinery ■ alcohol, sedatives and tranquilizers may increase drowsiness
Stop use and ask a doctor if
■ 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.
If pregnant or breast-feeding
ask a health professional before use
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children
OVERDOSAGE SECTION
In case of overdose, get medical help or contact a Poison Control Center 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
■ empty each Single-Use Vial of all liquid when dosing.
■ use the chart below to confirm the dose
| Age (Years) | Dose |
| Children under 4 years old | Do not use |
| Children 4 to under 12 years old | Ask a doctor |
| Adults and children 12 years and over | 1 Single Use Vial (30mL) every 4 hours while symptoms last Do not exceed 4 Single Use Vials in 24 hours |
Other information
■ each single-use vial (30 mL) contains 31mg of sodium
■ Store at 20-25oC (68-77oF)
■ Tamper Evident: do not use if the clear sealing label is broken or missing. Do not use if any vial is open or broken.
Inactive Ingredients
citric acid, edetate disodium, glycerin, maltitol, mixed berry flavor, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose, trisodium citrate, xanthan gum
Question or Comments?
1-800-719-9260
Package
Products#
Every source-derived product name is available through these pages.
- CVS Daytime and Nighttime Severe Cold and Flu Relief Bundle
- Acetaminophen, Dextromethorphan HBr, Guaifenesin, Doxylamine succinate, Phenylephrine HCl
- CVS Health Daytime Severe Cold and Flu Relief
- Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
- SORBITOL SOLUTION 70%
- WATER
- SODIUM METABISULFITE
- MALTITOL
- GLYCERIN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- POLYETHYLENE GLYCOL 600
- CITRIC ACID MONOHYDRATE
- TRISODIUM CITRATE DIHYDRATE
- ACETAMINOPHEN
- GUAIFENESIN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- XANTHAN GUM
- PROPYLENE GLYCOL
- SODIUM BENZOATE
- SUCRALOSE
- EDETATE DISODIUM
- CVS Nighttime Severe Cold and Flu Relief
- Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69842-495 | 69842-495-16 |
| 69842-499 | 69842-499-08 |
| 69842-497 | 69842-497-08 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| f086cd95-dca5-2a90-e053-2a95a90ab826 | c188874b-b48c-6cc9-e053-2995a90ae68c | 2022-12-23 | Warnings | f086cd95-dca5-2a90-e053-2a95a90ab826 c188874b-b48c-6cc9-e053-2995a90ae68c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.