Indications and uses
temporarily relieves common cold and flu symptoms minor aches and pains headache sore throat nasal congestion fever sinus congestion cough due to minor throat and bronchial irritation
Daytime Cold and Flu
- Manufacturer
- Lil' Drug Store Products, Inc
- Effective date
- 2025-12-04
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- full-release
- Hydrated at
- 2026-06-01 01:20:10
Label at a glance#
ProductDaytime Cold and Flu Lil Drug Store Products
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections
Dosage and administration
do not take more than directed (see Overdose warning ) do not take more than 4 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. keep dosing cup with product mL = milliliter adults and children 12 years and over 30 mL every 4 hours children 6 to under 12 years 15 mL every 4 hours children 4 to under 6 years ask a doctor children under 4 years do not use when usi...
Storage and handling
each 15 mL contains: sodium 12 mg store between 20-25°C (68-77°F). Do not refrigerate.
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active ingredients (in each 15 mL) | Purposes |
|---|---|
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 10 mg | Cough suppressant |
| Phenylephrine HCl 5 mg | Nasal decongestant |
Uses
- temporarily relieves common cold and flu symptoms
- minor aches and pains
- headache
- sore throat
- nasal congestion
- fever
- sinus congestion
- cough due to minor throat and bronchial irritation
Warnings
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if:
- adult takes more than 4 doses (30 mL each) of acetaminophen in 24 hours, which is the maximum daily amount
- child takes more than 4 doses (15 mL each) in 24 hours
- taken with other drugs containing acetaminophen
- adult has 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 an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- cough that occurs with too much phlegm (mucus)
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 exceed recommended dosage.
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough gets worse, or lasts more than 5 days (children) or 7 days (adult)
- 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 - PREGNANCY OR BREAST FEEDING SECTION
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.
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 4 doses in any 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device.
- keep dosing cup with product
- mL = milliliter
| adults and children 12 years and over | 30 mL every 4 hours |
| children 6 to under 12 years | 15 mL every 4 hours |
| children 4 to under 6 years | ask a doctor |
| children under 4 years | do not use |
- when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing
Other information
- each 15 mL contains: sodium 12 mg
- store between 20-25°C (68-77°F). Do not refrigerate.
Inactive ingredients
citric acid, FD&C yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum
Questions or comments?
Call toll free 1-877-507-6516 (M-F 8AM-4:30PM CST)
PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label
[Quality Guaranteed caduceus]
Compare to the Active
Ingredients in Vicks ®
DayQuil™ Cold & Flu*
Non-Drowsy
Cold & Flu
Daytime
Acetaminophen, 325 mg,
Pain Reliever/Fever Reducer
Dextromethorphan HBr 10 mg, Cough Supressant
Phenylephrine HCl 5 mg, Nasal Decongestant
Relieves
• Sore Throat • Aches
• Fever • Cough
• Nasal Congestion
For ages 6 years and over
8 FL OZ
(237 mL)
[Lil' Drug Store logo]
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | 7 |
| 1113705 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | 7 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 7 |
| 1113705 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 7 |
| 1113705 | APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SY | 7 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 66715-6931-4 | Daytime Cold and FluLil Drug Store Products | 237 mL in 1 BOTTLE, PLASTIC | LIQUID | 237 | 7 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Acetaminophen | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| Dextromethorphan Hydrobromide | ACTIVE INGREDIENT | 9D2RTI9KYH | 1 | |
| Phenylephrine Hydrochloride | ACTIVE INGREDIENT | 04JA59TNSJ | 1 | |
| Acetaminophen | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| Dextromethorphan | ACTIVE MOIETY | 7355X3ROTS | 1 | |
| Phenylephrine | ACTIVE MOIETY | 1WS297W6MV | 1 | |
| Citric Acid Monohydrate | INACTIVE INGREDIENT | 2968PHW8QP | 1 | |
| FD&C Yellow No. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 1 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| Polyethylene Glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| Propylene Glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| Saccharin Sodium | INACTIVE INGREDIENT | SB8ZUX40TY | 1 | |
| Sodium Citrate | INACTIVE INGREDIENT | 1Q73Q2JULR | 1 | |
| Sucrose | INACTIVE INGREDIENT | C151H8M554 | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Daytime Cold and Flu Lil Drug Store Products
- Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride
- CITRIC ACID MONOHYDRATE
- FD&C YELLOW NO. 6
- GLYCERIN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- SUCROSE
- SODIUM CITRATE, UNSPECIFIED FORM
- SACCHARIN SODIUM
- WATER
- PROPYLENE GLYCOL
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 66715-6931 | 66715-6931-4 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | LIQUID / ORAL | 29008 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | LIQUID / ORAL | 29008 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | LIQUID / ORAL | 2400 mg | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | LIQUID / ORAL | 3 mg | ||
| FD&C Yellow No. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | LIQUID / ORAL | 0.2 mg/1ml | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | LIQUID / ORAL | 114 mg | ||
| Sucrose | SUCROSE | C151H8M554 | LIQUID / ORAL | 37500 mg | ||
| Sucrose | SUCROSE | C151H8M554 | LIQUID / ORAL | 37500 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | LIQUID / ORAL | 114 mg | ||
| FD&C Yellow No. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | LIQUID / ORAL | 0.2 mg/1ml | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | LIQUID / ORAL | 2400 mg | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | LIQUID / ORAL | 3 mg |
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 |
|---|---|---|---|---|---|---|
| Daytime Cold and Flu Lil Drug Store Products | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Lil' Drug Store Products, Inc | fd5c20ed-5520-4db0-bfd4-995f043af2a4 | 2025-12-04 | Warnings | 66715-6931-4 66715-6931 66715693104 4522e7fd-f72b-080c-e063-6294a90a6565 fd5c20ed-5520-4db0-bfd4-995f043af2a4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.