Indications and uses
temporarily relieves common cold/flu symptoms: sore throat headache minor aches and pains fever runny nose and sneezing cough due to minor throat and bronchial irritation
Lil Drug Store Nighttime Cold and Flu
- Manufacturer
- Lil' Drug Store Products, Inc.
- Effective date
- 2020-10-05
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:13:25
Label at a glance#
ProductCold and Flu Nighttime
Active ingredientAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
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 6 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 15 mg | Cough suppressant |
| Doxylamine succinate 6.25 mg | Antihistamine |
Uses
- temporarily relieves common cold/flu symptoms:
- sore throat
- headache
- minor aches and pains
- fever
- runny nose and sneezing
- 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 daily 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
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema
- cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- do not exceed recommended dosage
- excitability may occur, especially in children
- avoid alcoholic drinks
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- pain 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.
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 6 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 - 66715-6834
QUALITY
⋆ GUARANTEED ⋆
Compare to the Active Ingredients in
Vicks® NyQuil® LiquiCaps®**
Cold & Flu
Nighttime
Acetaminophen, Dextromethorphan HBr, and Doxylamine Succinate
Pain Reliever/Fever Reducer, Cough Suppressant, Antihistamine
Relieves
• Sneezing • Runny Nose
• Cough • Aches
• Fever • Sore Throat
ACTUAL SIZE
12
Softgels
Lil'
Drug Store®
PRINCIPAL DISPLAY PANEL - 12 Softgel Blister Pack Carton - 66715-6847
QUALITY
⋆ GUARANTEED ⋆
Compare to the Active Ingredients in
Vicks® NyQuil® LiquiCaps®**
Cold & Flu
Nighttime
Acetaminophen, Dextromethorphan HBr, and Doxylamine Succinate
Pain Reliever/Fever Reducer, Cough Suppressant, Antihistamine
Relieves
• Sneezing • Runny Nose
• Cough • Aches
• Fever • Sore Throat
ACTUAL SIZE
12
Softgels
Lil'
Drug Store®
PRINCIPAL DISPLAY PANEL - 12 Softgel Blister Pack Carton - 66715-6734
QUALITY
⋆ GUARANTEED ⋆
Compare to the Active Ingredients in
Vicks® NyQuil® LiquiCaps®**
Cold & Flu
Nighttime
Acetaminophen, Dextromethorphan HBr, and Doxylamine Succinate
Pain Reliever/Fever Reducer, Cough Suppressant, Antihistamine
Relieves
• Sneezing • Runny Nose
• Cough • Aches
• Fever • Sore Throat
ACTUAL SIZE
12
Softgels
Lil'
Drug Store®
PRINCIPAL DISPLAY PANEL - 12 Softgel Blister Pack Carton - 66715-6848
QUALITY
⋆ GUARANTEED ⋆
Compare to the Active Ingredients in
Vicks® NyQuil® LiquiCaps®**
Cold & Flu
Nighttime
Acetaminophen, Dextromethorphan HBr, and Doxylamine Succinate
Pain Reliever/Fever Reducer, Cough Suppressant, Antihistamine
Relieves
• Sneezing • Runny Nose
• Cough • Aches
• Fever • Sore Throat
ACTUAL SIZE
12
Softgels
Lil'
Drug Store®
PRINCIPAL DISPLAY PANEL - 12 Softgel Blister Pack Carton - 66715-6849
QUALITY
⋆ GUARANTEED ⋆
Compare to the Active Ingredients in
Vicks® NyQuil® LiquiCaps®**
Cold & Flu
Nighttime
Acetaminophen, Dextromethorphan HBr, and Doxylamine Succinate
Pain Reliever/Fever Reducer, Cough Suppressant, Antihistamine
Relieves
• Sneezing • Runny Nose
• Cough • Aches
• Fever • Sore Throat
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 | |
| Doxylamine Succinate | ACTIVE INGREDIENT | V9BI9B5YI2 | 1 | |
| Acetaminophen | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| Dextromethorphan | ACTIVE MOIETY | 7355X3ROTS | 1 | |
| Doxylamine | ACTIVE MOIETY | 95QB77JKPL | 1 | |
| D&C yellow NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | 1 | |
| FD&C blue NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 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 Nighttime
- Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate
- Acetaminophen
- Dextromethorphan Hydrobromide
- Dextromethorphan
- Doxylamine Succinate
- Doxylamine
- D&C Yellow No. 10
- FD&C Blue No. 1
- GELATIN, UNSPECIFIED
- Glycerin
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE, UNSPECIFIED
- PROPYLENE GLYCOL
- Water
- Sorbitan
- Sorbitol
- Titanium Dioxide
- Lil Drug Store Nighttime Cold and Flu
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 66715-6834 | 66715-6834-0 |
| 66715-6847 | 66715-6847-0 |
| 66715-6734 | 66715-6734-0 |
| 66715-6848 | 66715-6848-0 |
| 66715-6849 | 66715-6849-0 |
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 |
|---|---|---|---|---|---|---|
| FD&C blue NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, EXTENDED RELEASE / ORAL | 4 mg | ||
| Gelatin | GELATIN | 2G86QN327L | SOLUTION / INTRAVENOUS | 34.8 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | ELIXIR / ORAL | 9306 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM, AUGMENTED / TOPICAL | 8 %w/w | ||
| FD&C blue NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | FILM / SUBLINGUAL | 0.07 mg | ||
| FD&C blue NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / RECTAL | 3315 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, LIQUID FILLED / ORAL | 185 mg | ||
| FD&C blue NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOAP / TOPICAL | 0.01 %w/w | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / OPHTHALMIC | 1 %w/v | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | LIQUID / ORAL | 29008 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | EMULSION / TOPICAL | 7 %w/w | ||
| D&C yellow NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | SUSPENSION, EXTENDED RELEASE / ORAL | 1 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / ORAL | 27120 mg | ||
| D&C yellow NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | GUM, CHEWING / BUCCAL | 24 mg | ||
| FD&C blue NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, DELAYED RELEASE / ORAL | 2 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 1.04 %w/v | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM / BUCCAL | 1.48 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / VAGINAL | 227.9 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CLOTH / TOPICAL | 0.03 mg/mg | ||
| Sorbitol | SORBITOL | 506T60A25R | CAPSULE / ORAL | 1111 mg | ||
| Gelatin | GELATIN | 2G86QN327L | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 14 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | DROPS / NASAL | 10 mg/1ml | ||
| Povidones | POVIDONE | FZ989GH94E | SUSPENSION / ORAL | 20 mg/5ml | ||
| Povidones | POVIDONE | FZ989GH94E | IMPLANT / SUBCUTANEOUS | 6 mg | ||
| Gelatin | GELATIN | 2G86QN327L | SOLUTION / ORAL | 34.8 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | PASTE / DENTAL | 14.6 %w/w | ||
| Povidones | POVIDONE | FZ989GH94E | TABLET / SUBLINGUAL | 6 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | LOTION / TOPICAL | 3990 mg | ||
| Gelatin | GELATIN | 2G86QN327L | TABLET, DELAYED RELEASE / ORAL | 19 mg | ||
| Gelatin | GELATIN | 2G86QN327L | INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS | 14 mg | ||
| FD&C blue NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, COATED / ORAL | 0.52 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / TOPICAL | 5.28 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / AURICULAR (OTIC) | 25 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / DENTAL | NA | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / TRANSDERMAL | 306.2 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAVENOUS | 15 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | GUM, CHEWING / BUCCAL | 230 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / RESPIRATORY (INHALATION) | 25 %w/w | ||
| Gelatin | GELATIN | 2G86QN327L | TABLET, ORALLY DISINTEGRATING / ORAL | 120 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | INJECTION, SOLUTION / SUBCUTANEOUS | 4.7 %w/v | ||
| Povidones | POVIDONE | FZ989GH94E | SUSPENSION/ DROPS / OPHTHALMIC | 0.6 %w/v | ||
| D&C yellow NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET, EXTENDED RELEASE / ORAL | 14 mg | ||
| FD&C blue NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / ORAL | 1.13 mg/15ml | ||
| FD&C blue NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SOLUTION / ORAL | 0.04 mg/5ml | ||
| FD&C blue NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SYRUP / ORAL | 0.05 mg/5ml | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET / ORAL | 64 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY, METERED / NASAL | 240 mg | ||
| D&C yellow NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | SYRUP / ORAL | 4 mg | ||
| Gelatin | GELATIN | 2G86QN327L | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 1 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | TABLET, FILM COATED / ORAL | 5 mg | ||
| D&C yellow NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | ELIXIR / ORAL | 0.3 mg/15ml | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / OPHTHALMIC | 12 mg | ||
| FD&C blue NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | PASTE, DENTIFRICE / DENTAL | NA | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, EMULSION / INTRAVENOUS | 24100 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, DELAYED RELEASE / ORAL | 1.7 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL, METERED / TOPICAL | 1225 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SHAMPOO, SUSPENSION / TOPICAL | 2 %w/w | ||
| Povidones | POVIDONE | FZ989GH94E | TABLET, FOR SUSPENSION / ORAL | 2 mg | ||
| Povidones | POVIDONE | FZ989GH94E | DROPS / ORAL | NA |
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 |
|---|---|---|---|---|---|---|
| 8c2b67bd-6257-4aed-8db2-cfb91ce8c417 | f2b43b3f-c272-49c7-a601-954e2e4865d6 | 2020-10-05 | Warnings | 8c2b67bd-6257-4aed-8db2-cfb91ce8c417 f2b43b3f-c272-49c7-a601-954e2e4865d6 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.