Label: MULTI SYMPTOM SEVERE COLD- acetaminophen, dextromethorphan hbr, phenylephrine hcl powder, for solution
- NDC Code(s): 55319-547-06
- Packager: FAMILY DOLLAR SERVICES INC
- 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.
Drug Label Information
Updated July 13, 2023
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- Official Label (Printer Friendly)
- Active ingredients (in each packet)
- Purposes
- Uses
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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- more than 4,000 mg of acetaminophen in 24 hours
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- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions, Symptoms may include:
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- skin reddening
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- blisters
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- 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.
Do not use
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- in a child under 12 years of age
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- if you are allergic to acetaminophen
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a pharmacist.
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- 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 a MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
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- liver disease
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- heart disease
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- high blood pressure
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- thyroid disease
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- diabetes
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- trouble urinating due to an enlarged prostate gland
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- cough that occurs with too much phlegm (mucus)
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- cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
Stop use and ask a doctor if
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- nervousness, dizziness, or sleeplessness occurs
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- fever gets worse or lasts more than 3 days
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- redness or swelling is present
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- new symptoms occur
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- pain, cough or nasal congestion gets worse or lasts more than 7 days
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- cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.
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Directions
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- do not use more than directed
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- take every 4 hours, while symptoms persist .do not take more than 6 packets in 24 hours unless directed by a doctor
Age
Dose
Adults and children 12 years of age and over
One packet
Children under 12 years of age
Do not use
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- dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10 - 15 minutes.
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- 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
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Principal Display
Compare to the active ingredients in Theraflu Multi-Symptom Severe Cold*
NDC 55319-547-06
MULTI-SYMPTOM
SEVERE COLD
Acetaminophen
Pain Reliever/ Fever Reducer
Dextromethorphan HBr
Cough Suppressant
Phenylephrine HCl
Nasal Decongestant
Dye Free
- Relieves
- •
- cough
- •
- Nasal congestion
- •
- Sore throat pain
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- Headache
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- Body ache
- •
- Fever
Honey Lemon
6 PACKETS
TAMPER EVIDENT INNER UNIT: DO NOT USE IF SEALED PACKET IS TORN OR BROKEN.
*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu Multi-Symptom Severe Cold.
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INGREDIENTS AND APPEARANCE
MULTI SYMPTOM SEVERE COLD
acetaminophen, dextromethorphan hbr, phenylephrine hcl powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-547 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) CARAMEL (UNII: T9D99G2B1R) MALTODEXTRIN (UNII: 7CVR7L4A2D) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SUCRALOSE (UNII: 96K6UQ3ZD4) SUCROSE (UNII: C151H8M554) Product Characteristics Color Score Shape Size Flavor HONEY (Honey Lemon) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-547-06 6 in 1 CARTON; Type 0: Not a Combination Product 07/03/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/03/2023 Labeler - FAMILY DOLLAR SERVICES INC (024472631)
