RITE AID DAYTIME SEVERE COLD AND COUGH RELIEF- acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride powder, for solution 
Rite Aid Corporation

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.

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Rite Aid® Daytime Severe Cold & Cough Relief

Drug Facts

Active ingredients (in each packet)Purposes
Acetaminophen 650 mgPain reliever/fever reducer
Dextromethorphan hydrobromide 20 mgCough suppressant
Phenylephrine hydrochloride 10 mgNasal decongestant

Uses

Warnings

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.

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 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.
  • 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
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • 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 the blood thinning drug warfarin

When using this product

  • do not exceed recommended dosage

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
  • pain, cough or nasal congestion gets worse or lasts more than 7 days
  • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health 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.

Directions

AgeDose
children under 4 years of agedo not use
children 4 to under 12 years of agedo not use unless directed by a doctor
adults and children 12 years of age and overone packet

Other information

Inactive ingredients

acesulfame potassium, aspartame, citric acid anhydrous, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, sodium citrate anhydrous, sucrose, and pregelatinized starch.

Questions or Comments?

Call 1-866-923-4914

DISTRIBUTED BY: RITE AID
30 HUNTER LANE, CAMP HILL, PA 17011

PRINCIPAL DISPLAY PANEL - 6 Packet Carton

RITE
AID
®
PHARMACY

SEE NEW WARNINGS INFORMATION & DIRECTIONS

*Compare to the active ingredients in
Theraflu® Severe Cold & Cough

daytime
severe cold
& cough relief

acetaminophen 650 mg
dextromethorphan HBr 20 mg
phenylephrine HCl 10 mg

pain reliever/fever reducer
cough suppressant &
nasal decongestant

relieves:
nasal & sinus congestion
cough
body ache
sore throat pain
headache
fever

berry infused
with menthol &
green tea flavors

6 PACKETS

PRINCIPAL DISPLAY PANEL - 6 Packet Carton
RITE AID DAYTIME SEVERE COLD AND COUGH RELIEF 
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-2112
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen650 mg
Dextromethorphan hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan hydrobromide20 mg
Phenylephrine hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine hydrochloride10 mg
Inactive Ingredients
Ingredient NameStrength
acesulfame potassium (UNII: 23OV73Q5G9)  
aspartame (UNII: Z0H242BBR1)  
anhydrous citric acid (UNII: XF417D3PSL)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-2112-76 in 1 CARTON; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/28/2013
Labeler - Rite Aid Corporation (014578892)

Revised: 4/2015
Document Id: a2d63bad-4e8e-4477-872a-750de9bc7f47
Set id: 14ca3278-8f48-4a46-b30f-35c41c5d5240
Version: 2
Effective Time: 20150421
 
Rite Aid Corporation