Nighttime Cold and Flu Multi Symptom Relief
- Manufacturer
- Shield Pharmaceuticals Corp
- Effective date
- 2026-01-24
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:34:34
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each softgel)
Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Uses
temporarily relieves common cold/flu symptoms:
• cough due to minor throat & bronchial irritation
• sore throat
• headache • minor aches & pains • fever • runny nose & sneezing
Warnings
Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take
• more than 8 Softgels in 24 hrs, which is the maximum daily amount for this product
• 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.
OTC - DO NOT USE SECTION
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.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
- liver disease
- glaucoma
- cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
- trouble urinating due to enlarged prostate gland
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin
OTC - WHEN USING SECTION
When using this product
• do not use more than directed n excitability may occur, especially in children
• marked drowsiness may occur
• avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery
• alcohol, sedatives, & tranquilizers may increase drowsiness
OTC - STOP USE SECTION
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
• 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.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 & for children even if you do not notice any signs or symptoms.
Directions
- take only as directed
- only use the dose cup provided
- do not exceed 4 doses per 24 hrs
| adults & children 12 yrs & over | 30 mL every 6 hrs |
| children 4 to under 12 yrs | ask a doctor |
| children under 4 yrs | do not use |
Other information
- each 30 mL contains:sodium 24 mg
- store between 20-25°C (68-77°F) and do not refrigerate.
Inactive ingredients
alcohol, citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum
Questions or comments?
1-800-373-6981(toll-free)
SPL UNCLASSIFIED SECTION
Distributed by:
Shield Pharmaceuticals Corp.
Ronkonkoma, NY 11779
PRINCIPAL DISPLAY PANEL
ValuRx
Nighttime Cold & Flu
Multi-Symptom Relief
Label
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| DOXYLAMINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83059-0125-4 | Nighttime Cold and Flu Multi Symptom Relief | 118 mL in 1 BOTTLE | LIQUID | 118 | 2 |
Products#
Every source-derived product name is available through these pages.
- Nighttime Cold and Flu Multi Symptom Relief
- Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
- CITRIC ACID
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- GLYCERIN
- PROPYLENE GLYCOL
- WATER
- SACCHARIN SODIUM
- SODIUM BENZOATE
- SODIUM CHLORIDE
- SORBITOL
- SUCRALOSE
- XANTHAN GUM
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 83059-0125 | 83059-0125-4 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CITRIC ACID | 2968PHW8QP | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SODIUM CHLORIDE | 451W47IQ8X | IACT |
| SORBITOL | 506T60A25R | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| DOXYLAMINE SUCCINATE | V9BI9B5YI2 | ACTIB |
Source Document#
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 |
|---|---|---|---|---|---|---|
| 573537ce-4749-b072-e063-6394a90a0b04 | 38d14e50-6d8a-4569-a2db-aa5b86ffb6cd | 2026-07-22 | Warnings | 38d14e50-6d8a-4569-a2db-aa5b86ffb6cd |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

