Other
Drug Facts
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Headache Relief Pm (NDC 0363-9894). 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, reye's syndrome, allergy alert, liver warning, stomach bleeding warning, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
| Active ingredients (in each caplet) | Purposes |
|---|---|
| Acetaminophen 250 mg | Pain reliever |
| Aspirin 250 mg (NSAID)
nonsteroidal anti-inflammatory drug | Pain reliever |
| Diphenhydramine citrate 38mg | Nighttime sleep-aid |
Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Aspirin may cause a severe allergic reaction which may include:
This product contains acetaminophen. Severe liver damage may occur if you take
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
Ask a doctor or pharmacist before use if you are taking a prescription drug for:
These could be signs of a serious condition
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last three months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
do not use more than directed
Benzoic acid , calcium carbonate, colloidal silicon dioxide, hydroxypropyl cellulose, iron oxide yellow, maltodextrin, magnesium stearate, microcrystalline cellulose Type 101, microcrystalline cellulose Type 112, medium chain triglycerides, Opadry Blue, pregelatinized corn starch, polysorbate 80, povidone K30, stearic acid, talc, zinc stearate
1-888-333-9792
Well at
Walgreens
NDC 0363-9894-12
WALGREENS PHARMACIST RECOMMENDED ‡
Headache
Relief PM
Acetaminophen / Pain Reliever
Aspirin
(NSAID) / Pain Reliever
Diphenhydramine Citrate / Nighttime Sleep Aid
NIGHTTIME
100 CAPLETS
Compare to Excedrin
® PM Headache Triple
Action Formula Caplets active ingredients
‡‡
* Please review the disclaimer below.