temporarily relieves these symptoms due to a cold: minor aches and pains minor sore throat pain headache nasal and sinus congestion runny nose sneezing itchy nose or throat itchy, watery eyes due to hay fever cough due to minor throat and bronchial irritation temporarily reduces fever
do not use more than directed take every 4 hours; do not take more than 5 packets in 24 hours unless directed by a doctor Age Dose children under 4 years of age do not use children 4 to under 12 years of age do not use unless directed by a doctor adults and children 12 years of age and over one packet dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes. if...
each packet contains: potassium 4 mg, sodium 27 mg phenylketonurics: contains phenylalanine 34 mg per packet store at controlled room temperature 20°-25°C (68°-77°F). Protect product from heat and moisture.
Drug Facts
| Active ingredients (in each packet) | Purposes |
|---|---|
| Acetaminophen 650 mg | Pain reliever/fever reducer |
| Diphenhydramine hydrochloride 25 mg | Antihistamine/cough suppressant |
| Phenylephrine hydrochloride 10 mg | Nasal decongestant |
Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
This product contains acetaminophen. Severe liver damage may occur if you take
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.
Ask a doctor or pharmacist before use if you are taking
If pregnant or breast-feeding, ask a heath care professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
| Age | Dose |
|---|---|
| children under 4 years of age | do not use |
| children 4 to under 12 years of age | do not use unless directed by a doctor |
| adults and children 12 years of age and over | one packet |
acesulfame potassium, aspartame, citric acid anhydrous, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, sodium citrate anhydrous, sucrose, and pregelatinized starch.
Call 1-800-ShopRite
Distributed By: Wakefern Food Corp.
5000 Riverside Drive
Keasbey, NJ 08832
Compare to: Active Ingredients in Theraflu® Nighttime Severe Cold & Cough
See New Warnings
Information & Directions
ShopRite®
Nighttime
FLU & SEVERE
COLD & COUGH
ACETAMINOPHEN
Pain Reliever/Fever Reducer
DIPHENHYDRAMINE HCl
Antihistamine/Cough Suppressant
PHENYLEPHRINE HCl
Nasal Decongestant
Nasal Congestion, Cough, Runny Nose, Sneezing,
Body Ache, Sore Throat Pain, Headache, Fever
Honey Lemon Infused
with Chamomile & White Tea Flavor
6 PACKETS
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1659960 | acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral Solution | PSN | 1 |
| 1659960 | acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution | SCD | 1 |
| 1659960 | acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Packet for Oral Solution | SY | 1 |
| 1659960 | acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution | SY | 1 |
| 1659960 | APAP 650 MG / Diphenhydramine Hydrochloride 25 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral Solution | SY | 1 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 41190-113-07 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-0229-f424-e053-dadaa90a57ce | ShopRite ® Nighttime Flu + Severe Cold & Cough |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 41190-113-07 | ShopRite Nighttime Flu Plus Severe Cold and Cough | 5 in 1 CARTON | POWDER, FOR SOLUTION | 5 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 41190-113 | SHOPRITE NIGHTTIME FLU PLUS SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [WAKEFERN FOOD CORPORATION] | 1 | Legacy NDC, 1 package rows | 20150204_1e0d1d59-8856-4914-b4dd-9050ab8086a0.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Acetaminophen | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| Diphenhydramine hydrochloride | ACTIVE INGREDIENT | TC2D6JAD40 | 1 | |
| Phenylephrine hydrochloride | ACTIVE INGREDIENT | 04JA59TNSJ | 1 | |
| Acetaminophen | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| Diphenhydramine | ACTIVE MOIETY | 8GTS82S83M | 1 | |
| Phenylephrine | ACTIVE MOIETY | 1WS297W6MV | 1 | |
| acesulfame potassium | INACTIVE INGREDIENT | 23OV73Q5G9 | 1 | |
| anhydrous citric acid | INACTIVE INGREDIENT | XF417D3PSL | 1 | |
| anhydrous trisodium citrate | INACTIVE INGREDIENT | RS7A450LGA | 1 | |
| aspartame | INACTIVE INGREDIENT | Z0H242BBR1 | 1 | |
| D&C yellow no. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | 1 | |
| FD&C blue no. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C red no. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| maltodextrin | INACTIVE INGREDIENT | 7CVR7L4A2D | 1 | |
| sucrose | INACTIVE INGREDIENT | C151H8M554 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 41190-113 | 41190-113-07 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Acetaminophen | 362O9ITL9D | ACTIB |
| Diphenhydramine hydrochloride | TC2D6JAD40 | ACTIB |
| Phenylephrine hydrochloride | 04JA59TNSJ | ACTIB |
| acesulfame potassium | 23OV73Q5G9 | IACT |
| aspartame | Z0H242BBR1 | IACT |
| anhydrous citric acid | XF417D3PSL | IACT |
| D&C yellow no. 10 | 35SW5USQ3G | IACT |
| FD&C blue no. 1 | H3R47K3TBD | IACT |
| FD&C red no. 40 | WZB9127XOA | IACT |
| maltodextrin | 7CVR7L4A2D | IACT |
| anhydrous trisodium citrate | RS7A450LGA | IACT |
| sucrose | C151H8M554 | IACT |
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 |
|---|---|---|---|---|---|---|
| sucrose | SUCROSE | C151H8M554 | TABLET, CHEWABLE / ORAL | 7258 mg | ||
| maltodextrin | MALTODEXTRIN | 7CVR7L4A2D | TABLET, EXTENDED RELEASE / ORAL | 3239 mg | ||
| sucrose | SUCROSE | C151H8M554 | LOZENGE / BUCCAL | NA | ||
| D&C yellow no. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET, COATED / ORAL | 2.5 mg | ||
| D&C yellow no. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET / SUBLINGUAL | 0.23 mg | ||
| FD&C red no. 40 | FD&C RED NO. 40 | WZB9127XOA | SUSPENSION/ DROPS / ORAL | 1 mg | ||
| FD&C red no. 40 | FD&C RED NO. 40 | WZB9127XOA | GUM, CHEWING / BUCCAL | 48 mg | ||
| sucrose | SUCROSE | C151H8M554 | ELIXIR / ORAL | 18000 mg | ||
| aspartame | ASPARTAME | Z0H242BBR1 | TABLET, FOR SUSPENSION / ORAL | 15 mg | ||
| acesulfame potassium | ACESULFAME POTASSIUM | 23OV73Q5G9 | TABLET, FOR SUSPENSION / ORAL | 80 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION/ DROPS / OPHTHALMIC | 0.05 %w/v | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 48 mg | ||
| D&C yellow no. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | SOAP / TOPICAL | 1.4 %w/w | ||
| sucrose | SUCROSE | C151H8M554 | DROPS / ORAL | NA | ||
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SYRUP / ORAL | 0.05 mg/5ml | ||
| maltodextrin | MALTODEXTRIN | 7CVR7L4A2D | TABLET, CHEWABLE / ORAL | 292 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | SOLUTION / RESPIRATORY (INHALATION) | 5 mg | ||
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / RECTAL | 0.01 %w/v | ||
| anhydrous trisodium citrate | ANHYDROUS TRISODIUM CITRATE | RS7A450LGA | SOLUTION, CONCENTRATE / INTRAVENOUS | 24 mg | ||
| aspartame | ASPARTAME | Z0H242BBR1 | SUSPENSION / ORAL | 23 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | CREAM / TOPICAL | 1 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | AEROSOL / TOPICAL | 0.08 %w/w | ||
| maltodextrin | MALTODEXTRIN | 7CVR7L4A2D | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | NA | ||
| sucrose | SUCROSE | C151H8M554 | TABLET / ORAL | 4249 mg | ||
| anhydrous trisodium citrate | ANHYDROUS TRISODIUM CITRATE | RS7A450LGA | SOLUTION / TOPICAL | 0.1 %w/v | ||
| sucrose | SUCROSE | C151H8M554 | GRANULE / ORAL | NA | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 35 mg | ||
| maltodextrin | MALTODEXTRIN | 7CVR7L4A2D | TABLET, COATED / ORAL | 5.6 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET, EXTENDED RELEASE / ORAL | 312 mg | ||
| aspartame | ASPARTAME | Z0H242BBR1 | CAPSULE, EXTENDED RELEASE / ORAL | 3 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | PASTE / ORAL | 26 mg | ||
| anhydrous trisodium citrate | ANHYDROUS TRISODIUM CITRATE | RS7A450LGA | SYRUP / ORAL | 156 mg | ||
| aspartame | ASPARTAME | Z0H242BBR1 | GRANULE, FOR SUSPENSION / ORAL | 420 mg | ||
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE / ORAL | 26.3 mg | ||
| maltodextrin | MALTODEXTRIN | 7CVR7L4A2D | SUSPENSION / ORAL | 6040 mg | ||
| FD&C red no. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, FILM COATED / ORAL | 2.5 mg | ||
| D&C yellow no. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | POWDER, FOR SOLUTION / ORAL | NA | ||
| FD&C red no. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / SUBLINGUAL | NA | ||
| sucrose | SUCROSE | C151H8M554 | SOLUTION / RECTAL | 35.42 %w/v | ||
| sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 18790 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | SOLUTION, CONCENTRATE / INTRAVENOUS | 60 mg | ||
| sucrose | SUCROSE | C151H8M554 | TABLET, DELAYED RELEASE / ORAL | 295.33 mg | ||
| acesulfame potassium | ACESULFAME POTASSIUM | 23OV73Q5G9 | GUM, CHEWING / BUCCAL | 147 mg | ||
| anhydrous trisodium citrate | ANHYDROUS TRISODIUM CITRATE | RS7A450LGA | INJECTION / INTRAMUSCULAR | 792 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION, EXTENDED RELEASE / ORAL | 62 mg | ||
| sucrose | SUCROSE | C151H8M554 | TROCHE / BUCCAL | NA | ||
| anhydrous trisodium citrate | ANHYDROUS TRISODIUM CITRATE | RS7A450LGA | FILM / SUBLINGUAL | 4 mg | ||
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SOLUTION / ORAL | 0.04 mg/5ml | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET / SUBLINGUAL | 36 mg | ||
| acesulfame potassium | ACESULFAME POTASSIUM | 23OV73Q5G9 | TABLET, FILM COATED / ORAL | 1.75 mg | ||
| anhydrous trisodium citrate | ANHYDROUS TRISODIUM CITRATE | RS7A450LGA | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 240 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS | 81 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | LOZENGE / TRANSMUCOSAL | 44 mg | ||
| anhydrous trisodium citrate | ANHYDROUS TRISODIUM CITRATE | RS7A450LGA | GRANULE, FOR SUSPENSION / ORAL | 4000 mg | ||
| anhydrous trisodium citrate | ANHYDROUS TRISODIUM CITRATE | RS7A450LGA | TABLET, CHEWABLE / ORAL | 72.5 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | LOTION / TOPICAL | 211 mg | ||
| FD&C red no. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, CHEWABLE / ORAL | 40 mg | ||
| maltodextrin | MALTODEXTRIN | 7CVR7L4A2D | CAPSULE / ORAL | 200 mg | ||
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LOTION / TOPICAL | NA | ||
| maltodextrin | MALTODEXTRIN | 7CVR7L4A2D | LOZENGE / ORAL | 175 mg |
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 |
|---|---|---|---|---|---|---|
| f11d78c0-2007-4c20-a664-7ebfca15d6e2 | 1e0d1d59-8856-4914-b4dd-9050ab8086a0 | 2015-01-29 | Warnings | f11d78c0-2007-4c20-a664-7ebfca15d6e2 1e0d1d59-8856-4914-b4dd-9050ab8086a0 |
Adverse event summaries are temporarily unavailable. Other product information remains available.