Daytime Cold and Flu Relief
Kroger DayTime Severe Cooling Cold and Flu Relief
494e69ef-dc9f-4e14-b856-5eaf0f541a03
HUMAN OTC DRUG LABEL
Aug 12, 2025
The Kroger Co.
DUNS: 006999528
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ACETAMINOHPEN, DEXTROMETHORPHAN HBr, GUAIFENESIN PHENYLEPHRINE HCL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (17)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Product Label

INDICATIONS & USAGE SECTION
Uses
- temporarily relieves common cold/flu symptoms:
- nasal congestion
- sinus congestion & pressure
- cough due to minor throat and bronchial irritation
- minor aches and pains
- headache
- fever
- sore throat
- reduce swelling of nasal passages
- temporarily restores freer breathing through the nose
- promotes nasal and/or sinus drainage
- help loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each 30 mL)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCl 10 mg
OTC - PURPOSE SECTION
Purposes
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
WARNINGS SECTION
Warnings
**Liver warning:**This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4 doses in 24 hrs which is maximum daily amount for this product
- taken 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 non-prescription). 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 an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- a sodium-restricted diet
Ask a doctor or pharmacist before use if you are
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 a rash or headache that lasts. These could be signs of a serious condition.
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
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.
DOSAGE & ADMINISTRATION SECTION
Directions
- take only as directed
- only use the dose cup provided
- do not exceed 4 doses per 24 hours
Adults & children 12 yrs & over |
30 mL every 4 hrs. |
Children 4 to under 12 yrs |
Ask a doctor |
Children under 4 yrs. |
Do not use |
OTHER SAFETY INFORMATION
Other information
*each 30 mL contains: sodium 81 mg
- store at room temperature. Do not refrigerate
INACTIVE INGREDIENT SECTION
Inactive ingredients
citric acid, D&C Yellow No. 10, disodium edetate, FD&C Blue No. 1, natural and artificial flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose
OTC - QUESTIONS SECTION
Questions or comments?
1-800-632-6900