DAYTIME COLD AND FLU
DAYTTIME COLD & FLU
0609120e-c348-494e-b4a0-863e77d7963a
HUMAN OTC DRUG LABEL
May 1, 2025
BI-MART
DUNS: 027630078
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
acetaminophen, dextromethorphan HBr, Phenylephrine HCl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (13)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
Uses
temporarily relieves common cold and flu symptoms:
- minor aches and pains
- headache
- sore throat
- fever
- nasal congestion
- cough due to minor throat and bronchial irritation
OTC - STOP USE SECTION
Stop use and ask a doctor if
- you get nervous, dizzy or sleepless
- pain, nasal congestion or cough get worse or last more than 5 days (children) or 7 days (adults)
- 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.
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin.
OTC - WHEN USING SECTION
When using this product
- do not use more than directed (see overdose warning)
- avoid alcoholic drinks
OTC - ACTIVE INGREDIENT SECTION
Drug Facts
Active ingredients (in each 15 mL dose cup)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
OTC - PURPOSE SECTION
Purpose
Pain reliever/fever reducer
Cough Suppressant
Nasal Decongestant
WARNINGS SECTION
Warnings
**Liver warning:**This product contains acetaminophen. Sever liver damage may occur if:
- adults and children over 12 years of age take more than 4 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product
- children 6 to 12 years of age take more than 4 doses (15 mL each) in 24 hours, which is the maximum daily amount for this product
- take with other drug containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
**Allergy alert:**Acetaminophen may cause sever skin reactions. Symptoms may include:
- skin reddening
- blisters
- ras
If skin reaction occurs, stop use and seek medical help right away.
**Sore throat warning:**If sore throat is sever, lasts 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 products 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 diseas), or for 2 weeks after stopping the MAOI drugs. 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 o its ingredients
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- diabete
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- cough accompanied by excessive phlegm (mucus)
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding,
ask a health professional before use.
OVERDOSAGE SECTION
Overdose warning:
Taking more than the recommended dose (overdose) may cause serious health problemas including liver damamge. In case of accidental overdose, seek professional assistance or contact a Poison Control Center (1-800-222-1222) immediately. Quick medical attention is critical for adults as well as for children even if ou do not notice any signs or symptoms.
DOSAGE & ADMINISTRATION SECTION
Directions
- take only as directed (see Overdose warning)
- measure only with dose cup provided and keep dose cup with product
- mL=mililiter
- do not exceed 4 doses per 24 hours
Age |
Dose |
adults & children 12 years and over |
30 mL every 4 hours |
children 6 to under 12 years |
15 mL every 4 hours |
children under 6 years |
do not use |
OTHER SAFETY INFORMATION
Other information
***each 15 mL contains:**sodium 5 mg
- store at room temperature 15-30°C (59-86°C) and do not refrigerate
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
INACTIVE INGREDIENT SECTION
Inactive ingredients
Citric acid, FD&C Yellow No 6, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum
OTC - QUESTIONS SECTION
Questions or Comments?
1-844-912-4012