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Drug Facts
Distributed By: Wakefern Food Corp.
5000 Riverside Drive
Keasbey, NJ 08832
The following Structured Product Label (SPL) was submitted to the FDA by Wakefern Food Corporation for the product Shoprite Nighttime Flu Plus Severe Cold And Cough (NDC 41190-113). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, allergy alert, liver warning, sore throat warning, do not use, ask a doctor before use if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Distributed By: Wakefern Food Corp.
5000 Riverside Drive
Keasbey, NJ 08832
| 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
Compare to: Active Ingredients in Theraflu® Nighttime Severe Cold & Cough
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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
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