Label: RITE AID NIGHTTIME SEVERE COLD AND COUGH RELIEF- acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride powder, for solution
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated April 21, 2015
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
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
- 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
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
- in a child under 4 years of age
- if you are allergic to acetaminophen
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- with any other product containing diphenhydramine, even one used on the skin
- 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
- heart disease
- high blood pressure
- thyroid disease
- a sodium-restricted diet
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema, asthma or chronic bronchitis
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
Ask a doctor or pharmacist before use if you are taking
- sedatives or tranquilizers
- the blood thinning drug warfarin
When using this product
- do not exceed recommended dosage
- avoid alcoholic drinks
- marked drowsiness may occur
- alcohol, sedatives and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occurs
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- symptoms do not get better or worsen
- pain, cough or nasal congestion gets worse or lasts more than 7 days
- cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.
- 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 using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat.
- Other information
- Inactive ingredients
- Questions or Comments?
- SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 6 Packet Carton
SEE NEW WARNINGS INFORMATION & DIRECTIONS
*Compare to the active ingredients in
Theraflu® Severe Cold & Cough
& cough relief
acetaminophen 650 mg
diphenhydramine HCl 25 mg
phenylephrine HCl 10 mg
pain reliever/fever reducer
& nasal decongestant
sore throat pain
honey lemon infused with
chamomile & white tea flavors
INGREDIENTS AND APPEARANCE
RITE AID NIGHTTIME SEVERE COLD AND COUGH RELIEF
acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride powder, for solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-2113 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 650 mg Diphenhydramine hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine hydrochloride 25 mg Phenylephrine hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine hydrochloride 10 mg Inactive Ingredients Ingredient Name Strength acesulfame potassium (UNII: 23OV73Q5G9) aspartame (UNII: Z0H242BBR1) anhydrous citric acid (UNII: XF417D3PSL) D&C yellow no. 10 (UNII: 35SW5USQ3G) FD&C blue no. 1 (UNII: H3R47K3TBD) FD&C red no. 40 (UNII: WZB9127XOA) maltodextrin (UNII: 7CVR7L4A2D) anhydrous trisodium citrate (UNII: RS7A450LGA) sucrose (UNII: C151H8M554) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-2113-7 6 in 1 CARTON; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 06/28/2013 Labeler - Rite Aid Corporation (014578892)