Indications and uses
temporarily relieves common cold and flu symptoms minor aches and pains headache sore throat nasal congestion fever cough due to minor throat and bronchial irritation
Cold and Flu Daytime
- Manufacturer
- Lil' Drug Store Products, Inc
- Effective date
- 2020-10-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:12:13
Label at a glance#
ProductCold and Flu Daytime
Active ingredientAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Label structure14 sections
Dosage and administration
do not take more than directed (see Overdose warning ) do not take more than 4 doses in 24 hours adults and children 12 years and over: take 2 softgels with water every 4 hours swallow whole; do not crush, chew, or dissolve children under 12 years: do not use when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing
Storage and handling
store between 15°-30°C (59°-86°F) avoid excessive heat
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 softgel) | 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
- cough due to minor throat and bronchial irritation
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
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
- diabetes
- heart disease
- thyroid disease
- high blood pressure
- 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
- pain, cough, or nasal congestion gets worse or lasts more than 7 days
- nervousness, dizziness, or sleeplessness occur
- 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 can cause liver damage. 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 (see Overdose warning)
- do not take more than 4 doses in 24 hours
- adults and children 12 years and over: take 2 softgels with water every 4 hours
- swallow whole; do not crush, chew, or dissolve
- children under 12 years: do not use
- when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing
Other information
- store between 15°-30°C (59°-86°F)
- avoid excessive heat
Inactive ingredients
Questions or comments?
call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)
SPL UNCLASSIFIED SECTION
Distributed by:
Lil' Drug Store Products, Inc.
9300 Earhart Lane SW
Cedar Rapids, IA 52404
PRINCIPAL DISPLAY PANEL - 12 Softgel Blister Pack Carton - NDC 66715-6831
QUALITY
⋆ GUARANTEED ⋆
Compare to the Active Ingredients in
Vicks® DayQuil® LiquiCaps®**
Non-drowsy
Cold & Flu
Daytime
Acetaminophen, Dextromethorphan HBr, and Phenylephrine HCl
Pain Reliever/Fever Reducer, Cough Suppressant, Nasal Decongestant
Relieves
- Aches • Fever
- Sore Throat • Cough
- Nasal Congestion
ACTUAL SIZE
12
Softgels
Lil'
Drug Store®
PRINCIPAL DISPLAY PANEL - 12 Softgel Blister Pack Carton - NDC 66715-6851
QUALITY
⋆ GUARANTEED ⋆
Compare to the Active Ingredients in
Vicks® DayQuil® LiquiCaps®**
Non-drowsy
Cold & Flu
Daytime
Acetaminophen, Dextromethorphan HBr, and Phenylephrine HCl
Pain Reliever/Fever Reducer, Cough Suppressant, Nasal Decongestant
Relieves
- Aches • Fever
- Sore Throat • Cough
- Nasal Congestion
ACTUAL SIZE
12
Softgels
Lil'
Drug Store®
PRINCIPAL DISPLAY PANEL - 12 Softgel Blister Pack Carton - NDC 66715-6951
QUALITY
⋆ GUARANTEED ⋆
Compare to the Active Ingredients in
Vicks® DayQuil® LiquiCaps®**
Non-drowsy
Cold & Flu
Daytime
Acetaminophen, Dextromethorphan HBr, and Phenylephrine HCl
Pain Reliever/Fever Reducer, Cough Suppressant, Nasal Decongestant
Relieves
- Aches • Fever
- Sore Throat • Cough
- Nasal Congestion
ACTUAL SIZE
12
Softgels
Lil'
Drug Store®
PRINCIPAL DISPLAY PANEL - 12 Softgel Blister Pack Carton - NDC 66715-6852
QUALITY
⋆ GUARANTEED ⋆
Compare to the Active Ingredients in
Vicks® DayQuil® LiquiCaps®**
Cold & Flu
Daytime
Acetaminophen, Dextromethorphan HBr, and Phenylephrine HCl
Pain Reliever/Fever Reducer, Cough Suppressant, Nasal Decongestant
Relieves
• Aches • Fever
• Sore Throat • Cough
• Nasal Congestion
ACTUAL SIZE
12
Softgels
Lil'
Drug Store®
PRINCIPAL DISPLAY PANEL - 12 Softgel Blister Pack Carton - NDC 66715-6853
QUALITY
⋆ GUARANTEED ⋆
Compare to the Active Ingredients in
Vicks® DayQuil® LiquiCaps®**
Cold & Flu
Daytime
Acetaminophen, Dextromethorphan HBr, and Phenylephrine HCl
Pain Reliever/Fever Reducer, Cough Suppressant, Nasal Decongestant
Relieves
• Aches • Fever
• Sore Throat • Cough
• Nasal Congestion
ACTUAL SIZE
12
Softgels
Lil'
Drug Store®
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 | |
| Butylated Hydroxyanisole | INACTIVE INGREDIENT | REK4960K2U | 1 | |
| Butylated Hydroxytoluene | INACTIVE INGREDIENT | 1P9D0Z171K | 1 | |
| FD&C red No. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| FD&C yellow No. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 1 | |
| Gelatin | INACTIVE INGREDIENT | 2G86QN327L | 1 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| Polyethylene Glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| Povidones | INACTIVE INGREDIENT | FZ989GH94E | 1 | |
| Propylene Glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| Sorbitan | INACTIVE INGREDIENT | 6O92ICV9RU | 1 | |
| Sorbitol | INACTIVE INGREDIENT | 506T60A25R | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Cold and Flu Daytime
- Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride
- Acetaminophen
- Dextromethorphan Hydrobromide
- Dextromethorphan
- Phenylephrine Hydrochloride
- Phenylephrine
- Butylated Hydroxyanisole
- Butylated Hydroxytoluene
- FD&C red No. 40
- FD&C yellow No. 6
- GELATIN, UNSPECIFIED
- Glycerin
- Polyethylene Glycol, Unspecified
- Povidone, Unspecified
- Propylene Glycol
- Sorbitan
- Sorbitol
- Water
- Titanium Dioxide
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 66715-6831 | 66715-6831-0 |
| 66715-6851 | 66715-6851-0 |
| 66715-6951 | 66715-6951-0 |
| 66715-6852 | 66715-6852-0 |
| 66715-6853 | 66715-6853-0 |
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 | SUSPENSION / AURICULAR (OTIC) | 10 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION / OPHTHALMIC | 58 mg | ||
| Povidones | POVIDONE | FZ989GH94E | POWDER, FOR SUSPENSION / ORAL | 35 mg/5ml | ||
| Gelatin | GELATIN | 2G86QN327L | CAPSULE, EXTENDED RELEASE / ORAL | 1229 mg | ||
| Butylated Hydroxyanisole | BUTYLATED HYDROXYANISOLE | REK4960K2U | OINTMENT / TOPICAL | 0.01 %w/w | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | EMULSION / OPHTHALMIC | 1.5 %w/v | ||
| Butylated Hydroxyanisole | BUTYLATED HYDROXYANISOLE | REK4960K2U | GEL / TOPICAL | 7 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 63.4 %w/v | ||
| FD&C yellow No. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SOLUTION / ORAL | 75.3 mg/15ml | ||
| Sorbitol | SORBITOL | 506T60A25R | CONCENTRATE / ORAL | 600 mg/1ml | ||
| Gelatin | GELATIN | 2G86QN327L | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 1 mg | ||
| Povidones | POVIDONE | FZ989GH94E | CAPSULE, DELAYED RELEASE / ORAL | NA | ||
| Povidones | POVIDONE | FZ989GH94E | TABLET, COATED / ORAL | 49.2 mg | ||
| Gelatin | GELATIN | 2G86QN327L | TABLET, SUGAR COATED / ORAL | NA | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET / ORAL | 64 mg | ||
| Gelatin | GELATIN | 2G86QN327L | SYSTEM / TOPICAL | 1050 mg | ||
| Gelatin | GELATIN | 2G86QN327L | POWDER, FOR SUSPENSION / ORAL | NA | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | TABLET, FILM COATED / ORAL | 1.55 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | EMULSION / OPHTHALMIC | 3 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION, CONCENTRATE / ORAL | 200 mg/1ml | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CREAM / VAGINAL | 60 mg | ||
| Povidones | POVIDONE | FZ989GH94E | CAPSULE / ORAL | 300 mg | ||
| Povidones | POVIDONE | FZ989GH94E | TABLET, ORALLY DISINTEGRATING / ORAL | 15.03 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | POWDER, FOR SUSPENSION / ORAL | 12000 mg | ||
| FD&C red No. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, EXTENDED RELEASE / ORAL | 2.22 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | GUM, CHEWING / BUCCAL | 230 mg | ||
| Sorbitan | SORBITAN | 6O92ICV9RU | CAPSULE / ORAL | 19.08 mg | ||
| Butylated Hydroxyanisole | BUTYLATED HYDROXYANISOLE | REK4960K2U | OINTMENT / VAGINAL | 0.02 %w/w | ||
| Sorbitol | SORBITOL | 506T60A25R | AEROSOL, FOAM / TOPICAL | 4.95 %w/w | ||
| Butylated Hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CAPSULE / ORAL | 3 mg | ||
| Butylated Hydroxyanisole | BUTYLATED HYDROXYANISOLE | REK4960K2U | SUSPENSION / ORAL | 2.5 mg/5ml | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | LOTION, AUGMENTED / TOPICAL | 2070 mg | ||
| FD&C yellow No. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CONCENTRATE / ORAL | 0.03 mg/5ml | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION / AURICULAR (OTIC) | 0.05 %w/w | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED / ORAL | 96 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | LIQUID / ORAL | 53460 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, COATED / ORAL | 14.21 mg | ||
| Povidones | POVIDONE | FZ989GH94E | SUSPENSION / AURICULAR (OTIC) | NA | ||
| FD&C yellow No. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, CHEWABLE / ORAL | 0.41 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / SUBCUTANEOUS | 15 %w/v | ||
| Sorbitol | SORBITOL | 506T60A25R | SOLUTION / ORAL | 29268 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | TABLET, CHEWABLE / ORAL | 3555 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / OPHTHALMIC | 6 %w/v | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY / SUBLINGUAL | 36 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | INJECTION / SUBCUTANEOUS | 4.7 %w/v | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CONCENTRATE / ORAL | 7000 mg | ||
| FD&C yellow No. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, COATED PELLETS / ORAL | NA | ||
| FD&C red No. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / SUBLINGUAL | NA | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| Gelatin | GELATIN | 2G86QN327L | CAPSULE, COATED PELLETS / ORAL | 65 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL / TOPICAL | 19.2 %w/w | ||
| FD&C yellow No. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, LIQUID FILLED / ORAL | 1 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / OPHTHALMIC | 2.5 %w/v | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | PASTE / DENTAL | 0.5 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE / ORAL | 3487 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM, SOLUBLE / BUCCAL | 5 mg | ||
| Gelatin | GELATIN | 2G86QN327L | PASTE / DENTAL | 252 mg | ||
| FD&C red No. 40 | FD&C RED NO. 40 | WZB9127XOA | SYRUP / ORAL | 3 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / OPHTHALMIC | 0.6 %w/v | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT, AUGMENTED / TOPICAL | 714 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 |
|---|---|---|---|---|---|---|
| 63eb39c3-60c0-47f6-a7c4-ce8cfa4394c2 | b9cf59e7-e298-46a2-a3a0-abf23f8678f3 | 2020-10-09 | Warnings | 63eb39c3-60c0-47f6-a7c4-ce8cfa4394c2 b9cf59e7-e298-46a2-a3a0-abf23f8678f3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.